Abbreviation

Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)

Retrieved on:

목요일, 4월 18, 2024

21

Key Points:

21
Guideline on the requirements for demonstrating
therapeutic equivalence between orally inhaled products
(OIP) for asthma and chronic obstructive pulmonary
disease (COPD)

22

Table of contents

23

Executive summary ..................................................................................... 4

24

1.
Primary PK parameters to be analysed and acceptance criteria .............................. 14
43

Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024

51

6.4.
Definitions ........................................................................................... 18
56

List of Abbreviations.................................................................................. 20

57

Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024

58

Executive summary

59

This guideline is the 2nd revision of the CHMP Guideline formerly called ?Guideline on the requirements

60

for clinical documentation for orally inhaled products (OIP) including the requirements for

61

demonstration of therapeutic equivalence between two inhaled products for use in the treatment of

62

asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of

63

asthma in children and adolescents?.
It addresses the requirements for demonstration of therapeutic
64

equivalence (TE) between orally inhaled products containing the same active moiety(ies).
It is generally not recommended to aim at demonstrating TE using pharmacodynamic
70

or clinical endpoints as these are deemed insensitive.
This
83

guideline is directed particularly at the requirements for demonstrating TE between OIPs containing the

84

same active moiety(ies) and used in the management and treatment of patients with asthma and/or

85

COPD.
86
The guideline was first published as points to consider in 2004 and revised for the first time and

87

became guideline in 2009.
Since then, a number of Q&A documents have been published by Quality
88

Working Party (QWP) and former Pharmacokinetic Working Party (PKWP).
Scope
93

This document provides guidance on the requirements for demonstrating TE between OIPs, including

94

both, single active substance products and combination products.
Also, in the case that there is a need
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024

98

to confirm similarity to a product for which literature data is available (e.g., well-established use

99

applications), the same principles apply.
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024
132

4.
Products for nebulisation
177

This guideline applies also for products for nebulisation although it is acknowledged that the

178

performance of these is highly dependent on the nebuliser used.
In vitro criteria for demonstrating TE
206

The test and reference products should be compared in order to conclude on TE.
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024
211
212

2.
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024
353

6.2.
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024
392

6.3.
If the
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024
432

different strengths of the test and the reference product are not shown to be proportional in vitro, in

433

vivo equivalence should be demonstrated with a bracketing approach.
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024
471

6.4.
Griffin, 1964
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024

553

which both reference product-na?ve and experienced users should be included.
568
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024

569

10.
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024
Product strength

Product strength may be either the delivered
dose or the metered dose.
570
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024

571

List of Abbreviations
APSD

Aerodynamic Particle Size Distribution

AUC

Area Under the Curve

CHMP

Committee for Medicinal Products for Human
Use

CI

Confidence Interval

Cmax

Peak concentration

COPD

Chronic Obstructive Pulmonary Disease

DPI

Dry Powder Inhaler

FPD

Fine Particle Dose

GI

Gastrointestinal

ICH

International Conference on Harmonisation

IVIVC

In vitro in vivo correlation

MDI

Metered Dose Inhaler

OIP

Orally Inhaled Product

PD

Pharmacodynamic

PK

Pharmacokinetic

pMDI

Pressurised Metered Dose Inhaler

QWP

Quality Working Party

SmPC

Summary of Product Characteristics

TE

Therapeutic equivalence

tmax

Time to peak concentration

572

Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024

Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)

Retrieved on:

목요일, 4월 18, 2024

21

Key Points:

21
Guideline on the requirements for demonstrating
therapeutic equivalence between orally inhaled products
(OIP) for asthma and chronic obstructive pulmonary
disease (COPD)

22

Table of contents

23

Executive summary ..................................................................................... 4

24

1.
Primary PK parameters to be analysed and acceptance criteria .............................. 14
43

Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024

51

6.4.
Definitions ........................................................................................... 18
56

List of Abbreviations.................................................................................. 20

57

Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024

58

Executive summary

59

This guideline is the 2nd revision of the CHMP Guideline formerly called ?Guideline on the requirements

60

for clinical documentation for orally inhaled products (OIP) including the requirements for

61

demonstration of therapeutic equivalence between two inhaled products for use in the treatment of

62

asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of

63

asthma in children and adolescents?.
It addresses the requirements for demonstration of therapeutic
64

equivalence (TE) between orally inhaled products containing the same active moiety(ies).
It is generally not recommended to aim at demonstrating TE using pharmacodynamic
70

or clinical endpoints as these are deemed insensitive.
This
83

guideline is directed particularly at the requirements for demonstrating TE between OIPs containing the

84

same active moiety(ies) and used in the management and treatment of patients with asthma and/or

85

COPD.
86
The guideline was first published as points to consider in 2004 and revised for the first time and

87

became guideline in 2009.
Since then, a number of Q&A documents have been published by Quality
88

Working Party (QWP) and former Pharmacokinetic Working Party (PKWP).
Scope
93

This document provides guidance on the requirements for demonstrating TE between OIPs, including

94

both, single active substance products and combination products.
Also, in the case that there is a need
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024

98

to confirm similarity to a product for which literature data is available (e.g., well-established use

99

applications), the same principles apply.
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024
132

4.
Products for nebulisation
177

This guideline applies also for products for nebulisation although it is acknowledged that the

178

performance of these is highly dependent on the nebuliser used.
In vitro criteria for demonstrating TE
206

The test and reference products should be compared in order to conclude on TE.
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024
211
212

2.
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024
353

6.2.
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024
392

6.3.
If the
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024
432

different strengths of the test and the reference product are not shown to be proportional in vitro, in

433

vivo equivalence should be demonstrated with a bracketing approach.
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024
471

6.4.
Griffin, 1964
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024

553

which both reference product-na?ve and experienced users should be included.
568
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024

569

10.
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024
Product strength

Product strength may be either the delivered
dose or the metered dose.
570
Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024

571

List of Abbreviations
APSD

Aerodynamic Particle Size Distribution

AUC

Area Under the Curve

CHMP

Committee for Medicinal Products for Human
Use

CI

Confidence Interval

Cmax

Peak concentration

COPD

Chronic Obstructive Pulmonary Disease

DPI

Dry Powder Inhaler

FPD

Fine Particle Dose

GI

Gastrointestinal

ICH

International Conference on Harmonisation

IVIVC

In vitro in vivo correlation

MDI

Metered Dose Inhaler

OIP

Orally Inhaled Product

PD

Pharmacodynamic

PK

Pharmacokinetic

pMDI

Pressurised Metered Dose Inhaler

QWP

Quality Working Party

SmPC

Summary of Product Characteristics

TE

Therapeutic equivalence

tmax

Time to peak concentration

572

Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
chronic obstructive pulmonary disease (COPD)
EMA/CHMP/101453/2024

Greenridge Exploration Provides Technical Review of its Nut Lake Uranium Project in Thelon Basin, Nunavut

Retrieved on:

목요일, 4월 4, 2024

Element, Fracture, PD, Government, Database, Helium, VNIR, Project, Heartbreak, Anomaly, GXP, Magnetism, Geology, Abbreviation, Magnetometer, Water, Lens, SWIR, Dubawnt Lake, Fault, Map, Magnetic anomaly, Granite

VANCOUVER, British Columbia, April 04, 2024 (GLOBE NEWSWIRE) -- Greenridge Exploration Inc. (“Greenridge” or the “Company”) (CSE: GXP | FRA: HW3), is pleased to announce it has undertaken a detailed technical review of the Nut Lake Uranium Project (the “Nut Lake Property” or the “Project”) located in the Thelon Basin in Nunavut.

Key Points:

VANCOUVER, British Columbia, April 04, 2024 (GLOBE NEWSWIRE) -- Greenridge Exploration Inc. (“Greenridge” or the “Company”) (CSE: GXP | FRA: HW3), is pleased to announce it has undertaken a detailed technical review of the Nut Lake Uranium Project (the “Nut Lake Property” or the “Project”) located in the Thelon Basin in Nunavut.
The Project covers approximately 4,036 hectares near the Northern Tip of the Yathkyed Basin, a sub-basin of the Thelon Basin (Please see Figure 1).
Russell Starr, Chief Executive Officer of the Company, commented, “We continue to unveil more exciting geological information at the Nut Lake Uranium Project.
The Thelon Basin and sub basins are extremely underexplored compared to the world renowned Athabasca Basin just to the south.

AI Model Makes Hospital Notes Patient-Friendly

Retrieved on:

월요일, 3월 11, 2024

The research focuses on discharge notes written by doctors to capture patient's health status in the medical record as they are discharged from the hospital.

Key Points:

The research focuses on discharge notes written by doctors to capture patient's health status in the medical record as they are discharged from the hospital.
Specifically, running discharge notes through generative AI dropped the reports from an eleventh-grade reading level on average to a sixth grade level, the gold standard for patient education materials.
They also found that just 56% of notes created by AI were entirely complete.
Feldman notes that generative AI tools are sensitive, and asking a question of the tool in two subtly different ways may yield divergent answers.

ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1

Retrieved on:

화요일, 3월 12, 2024

Consensus, Duplication, Address, Fetus, Pregnancy, Translation, Health, Health care, Employment, Region, Draft, Guideline, Diagnosis, Domenico, Data set, Efficacy, Literature, Trial of the century, Mortality, Identifiability, Software, Social media, Adolescence, Committee, Marketing, Pharmacovigilance, Convulsion, INTRODUCTION, Agency, Data collection, Causality, Documentation, Data, European, CHMP, MRP, Public, Case management, Abuse, Child, Drug overdose, HCP, Digital platform, ADR, Responsibility, Language, Use, Chronology, Disulfiram-like drug, Calendar, Digital, Drug, Vaccine, Threshold limit value, Observation, Section 5, MAH, Safety, Gestational age, ICH, SAFETY, Abstract, Section 4, Clinical trial, Consumer, GOOD, Madiga, Abbreviation, Reproduction, Birth, Collection, EMA, Mutagen, Medical dictionary, Aes, Medicine, Registry, PSP, Content, MedDRA, Report, Seriousness, Nature, ICMJE recommendations, Risk, Communication, Step, Narrative, Autopsy, Approximation error, Death, Patient, Privacy, Role, Journalist, Publication, ICSR, Riau rupiah, Medical device

The completed comments form should be sent to

Key Points:

The completed comments form should be sent to
[email protected]
*For more information please refer to Public consultation explanatory note: Proposed E2B(R3) updates
to align with ICH E2D(R1) guideline.
18
July 2003
E2D

Approval by the Steering Committee under Step 4 and
recommendation for adoption to the three ICH
regulatory bodies.
12
November 2003
New
Codification
November
2005
E2D

E2D

Revision of E2D
Code

History

E2D(R1) Endorsement by the Members of the ICH Assembly
under Step 2 and release for public consultation.
Date
New
Codification

5 February 2024

E2D(R1)

POST-APPROVAL SAFETY DATA:
DEFINITIONS AND STANDARDS FOR MANAGEMENT AND
REPORTING OF INDIVIDUAL CASE SAFETY REPORTS
E2D(R1)
ICH Consensus Guideline
Table of Contents
1.
The ICH E2D guideline provides guidance on definitions and standards for post-
5

approval individual case safety reporting, as well as good case management practices.
Detailed guidance on the
9

specific structure, format, standards, and data elements for transmitting Individual Case Safety

10

Reports (ICSRs) is provided in the ICH E2B guideline.
Guidance on periodic reporting of
11

aggregated safety data is covered in the ICH E2C guideline.
12
This guideline provides recommendations that are harmonised to the extent possible given

13

differences in post-market safety reporting requirements among ICH regions.
25
2.1.2

Adverse Drug Reaction (ADR)

26

Adverse drug reactions, as defined by local and regional requirements, concern noxious and

27

unintended responses to a medicinal product.
66
Product labelling may include information related to ADRs for the pharmaceutical class to

67

which the medicinal product belongs.
In some cases, ?other observations? can occur
78

without any associated AEs/ADRs, while in other cases ?other observations? can occur with

79

an associated AE/ADR.
84
For the purpose of reporting, requirements in some regions refer only to ADRs, whereas other

85

regions refer to AEs.
86
Refer to local and regional requirements for specifications and requirements on the reporting

87

of AEs or ADRs to each Regulatory Authority.
89
2.2

90

An ICSR is a description of an AE/ADR or other observation in an individual patient at a specific

91

point of time.
Cases missing any of the above criteria do not qualify for reporting; due diligence
99

should be exercised to collect the missing criteria.
6
104

An ICSR can be a description of at least one AE/ADR, or other observation (see Section 5.1.3,

105

Other Observations), or both.
Primary sources, often referred
112

to as ?reporters?, include healthcare professionals and consumers who provide facts about a case

113

to the MAH or regulatory authority.
127
2.7

128

A digital platform is the software and technology used to enable transmission of information

129

between users (see Section 4.3, Digital Platforms).
Expedited Report
Primary Source

Healthcare Professional (HCP)

Consumer

Digital Platform

7

130

2.8

131

An organised data collection system (ODCS) is an activity that gathers data in a planned manner,

132

thereby enabling review to be performed.
MAHs should also follow the
286

advice in Section 5.1.2, Important Safety Findings, about communicating safety findings to

13

287

regulatory authorities.
MAHs may conduct an MRP
395

using a digital platform; in this situation the ICH E2B data element value for ?MRP? should be

396

selected.
564
Terms (e.g., AEs/ADRs, indication, and medical conditions) in the narrative should be accurately

565

reflected in appropriate ICH E2B data elements.
638
Regulatory Authorities and MAHs should consider and manage duplicates when reviewing

639

pharmacovigilance data, as duplicates negatively impact signal detection.
651
Duplicate detection relies on good quality data and is generally based on similarities but should

652

take into account that information in ICSRs may differ between reporters.

The Global Market for Advanced Automotive Technologies 2024-2040 - ResearchAndMarkets.com

Retrieved on:

화요일, 2월 27, 2024

The "Global Market for Advanced Automotive Technologies 2024-2040" report has been added to ResearchAndMarkets.com's offering.

Key Points:

The "Global Market for Advanced Automotive Technologies 2024-2040" report has been added to ResearchAndMarkets.com's offering.
The market for advanced automotive technologies is experiencing rapid growth as vehicles become more connected, electrified, autonomous and smart.
The Global Market for Advanced Automotive Technologies 2024-2040 provides a detailed analysis of the latest trends and technologies shaping the future of the automotive market.
The Global Market for Advanced Automotive Technologies 2024-2040 profiles over 800 companies.

Questions and answers on the European Union framework for (traditional) herbal medicinal products, including those from a ‘non-European’ tradition

Retrieved on:

일요일, 3월 10, 2024

Well, DER, Fungus, Capsule, TUR, Interest, Animal, Part, Exercise, Database, Viral, Hepatitis, Powder, Collection, Directive, Union, Nutrient, DSM-IV codes, Volume, CTD, Legislation, Literature, Fermentation, Diabetes, Pharmacopoeia, Inhalation, Committee, Monograph, NTA, WEU, DCP, AIDS, See, Mineral, Marketing, Safety, Plant, MRA, Autoimmunity, Directive 2001/83/EC, GMP, Documentation, Seed, Heart failure, Distillation, CHMP, MRP, European Medicines Agency, Guideline, Disorder, Mutual, Convention, State, Tablet, Community, Clinical trial, Rapporteur, European Commission, Woman, Medication package insert, Vitamin, Quality, Authority, GACP, SAWP, Pharmacovigilance, Civil service commission, HMPS, Science, Health, Bibliography, Section 4, Infection, Kampo, Commission, Abbreviation, Pathology, Prescription, Human, Medication, Reproduction, EMA, NCA, Chapter One, EDQM, TAM, European Pharmacopoeia, European Economic Area, Food, Regulation (European Union), COM, TCM, Administration, Mutual recognition, Procedure, Medicine, Herbal, Answer, Q&A, HIV, EudraLex, Cancer, Public, Medicinal plants

1

Key Points:

1
Committee on Herbal Medicinal Products (HMPC)
Questions & Answers on the European Union framework
for (traditional) herbal medicinal products, including those
from a ?non-European? tradition

Table of Content
1.
European Pharmacopoeia
SAWP

Scientific Advice Working Party

SmPC

Summary of Product Characteristics

THMP

Traditional Herbal Medicinal Product

TUR

Traditional Use Registration

WEU

Well-Established Use

Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Terminology of herbal medicinal products (Q&A 1-4)
Question 1
What are herbal substances, herbal preparations, and herbal medicinal products?
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Question 4
Are food supplements regulated under the European Union (EU) pharmaceutical legislation
for (traditional) herbal medicinal products ((T)HMPs)?
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Regulation of herbal medicinal products in the European Union (Q&A 511)
Question 5
Where to find the pharmaceutical legislation and dossier requirements for herbal medicinal
products (HMPs), including traditional herbal medicinal products (THMPs), in the European
Union (EU)?
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
These countries have,
through the EEA agreement, adopted the complete Union acquis on medicinal products and are
consequently parties to the Union procedures.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Specific provisions for traditional herbal medicinal products (Q&A 1221)
Question 12
Which indications can be granted for traditional herbal medicinal products (THMPs)?
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Nov. 2023
Answer 17
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Question 29
Does the Committee on Herbal Medicinal Products (HMPC) hold a specific database on
(registered) authorised (traditional) herbal medicinal products ((T)HMPs)?
Discussion with Member States intended to be
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.
Questions & Answers on the European Union framework for (traditional) herbal
medicinal products, including those from a ?non-European? tradition
EMA/HMPC/402684/2013 Rev.

Compilation of quality review of documents (QRD) on stylistic matters in product information

Retrieved on:

일요일, 3월 10, 2024

29 February 2024

Key Points:

29 February 2024
EMA/25090/2002 rev.23*
Human Medicines Division
Compilation of QRD decisions on stylistic matters in product information
Issues
Abbreviations

Connected problems
Subscript and superscript

QRD Suggestions
Acronyms must be written in their standard form; e.g.
Cmax, Cmax
Abbreviations and
Not always understood,

Non-standard abbreviations and acronyms should be avoided, and the term should be written out in full.
The same applies when stating the pharmaceutical form in section 3 of the SmPC and section 4 of the labelling;
i.e.
critical steps prior to administration of the product should also be included (section 5 of Annex IIIA).
Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002
Page 2/23

Issues

Connected problems

QRD Suggestions

emphasise in the labelling
the special handling prior
to administration of the
product.
Consistency
Inconsistencies in style are

Once a particular style or house style has been selected, it must be used consistently throughout the text.
Tradename 150 mg solution for injection in pre-filled syringe
Tradename 150 mg solution for injection in pre-filled pen
information annexes?
Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002
Page 3/23

Issues
Desiccant

Connected problems

QRD Suggestions

For medicinal products

The foil of blister packs containing a desiccant must be clearly labelled to show which blister pocket contains

packaged with a desiccant

the desiccant.
For bottles containing a desiccant, a similar statement should also be considered provided there
mistake the desiccant for a

is available space.
It can only be included in brackets in section 3 of the
where can this be

SmPC and section 4 of the labelling.
Direct speech should only
be used in section 6 of the SmPC for instructions about shelf-life, storage, handling and disposal.
The term ?drug? though can be used in the product information annexes when it is part of a standard set of
terms (e.g.
Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002
Page 5/23

Issues
Foreign terms

Connected problems

QRD Suggestions

Foreign terms, particularly

Foreign terms must be written in italics; e.g.
Patients can be referred to as ?he? or
physician is often referred

as ?she? when the medicinal product is exclusively for use by males or females.
if the product in question might be
measurements are

used by elderly patients), in brackets after the metric measures in the English text.
Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002
Page 6/23

Issues

Connected problems

QRD Suggestions

product name is composed
of MAH+INN?
Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002
Page 7/23

Issues

Connected problems

QRD Suggestions
MT: English
BG: Bulgarian
NL: Dutch
CZ: Czech or English at applicant?s discretion.
Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002
Page 14/23

Issues

Connected problems

QRD Suggestions
considered, e.g.
Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002
Page 16/23

Issues
Symbols: Non-Unicode

Connected problems

QRD Suggestions

The use of non-Unicode

Only Unicode symbols must be used in submitted product information annexes.
Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002
Page 20/23

Issues

Connected problems

Units: SI base units -

International Standard

litre

base units have been
introduced in the European
Union with Council
Directive 80/181/EEC of
20.12.79 (O.J.
Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002
Page 23/23

i-80 Gold Provides High-Grade Results from Drilling at Ruby Hill

Retrieved on:

월요일, 2월 26, 2024

Carbonate, Property, PB, FAD, Zinc, TSX, Ruby, Sedimentary exhalative deposits, Growth, Lead, History, Gold, GOLD, Abbreviation, CRD, Silver, Archimedes, Rare-earth element

Drilling completed between 2022 and 2024 at the Blackjack, Hilltop and FAD deposits intersected significant high-grade mineralization with all deposits remaining open for expansion.

Key Points:

Drilling completed between 2022 and 2024 at the Blackjack, Hilltop and FAD deposits intersected significant high-grade mineralization with all deposits remaining open for expansion.
The polymetallic (base metal) resource estimate is being completed as part of the Company's plan to advance mine development at Ruby Hill with underground workings accessing both the gold and polymetallic deposits.
These discoveries highlight the geological potential for Ruby Hill to host some of the highest-grade polymetallic mineralization known world‑wide.
FAD is the most gold-rich of the polymetallic mineralized zones at Ruby Hill.

Digital technologies have made the wonders of ancient manuscripts more accessible than ever, but there are risks and losses too

Retrieved on:

목요일, 2월 8, 2024

Library of Congress, Handwriting, Justice, Computer, JPEG, Ink, Collection, Dog, British, Language, Translation, Darkness, Bible, Manuscript, Printing, AI, Tourism, System, Spirituality, Element, Smoke, Book, Abbreviation, Identity theft, Congress, Archive, Digital, PDF, Tablet, Dust, Rhysida, Painting, Water, Pet, Shorthand, Learning, Beauty, Library, Knowledge, Digitization

And even if some few have somehow survived, they are moth-eaten and in a state of decay, and remembered about as well as if they had never existed.

Key Points:

And even if some few have somehow survived, they are moth-eaten and in a state of decay, and remembered about as well as if they had never existed.
By making the manuscripts into a book, he would preserve the knowledge they contained – but not the manuscript, not the artefact itself.
He does not mention how difficult his Byzantine manuscripts were to read and transcribe, even for someone familiar with the language.
Every manuscript is its own text, its own space of knowledge, and an irreplaceable part of our shared cultural histories.

Preserving the Past

Our knowledge of the past, and the wisdom we can gain from it, is bound in material objects – whether manuscripts, paintings, ruined buildings or clay pots – that are decaying.
What will we preserve of the past?
We are lucky if we can now read a text in 50 manuscripts.
Read more:
Uncovering the mysteries of The Book of Kells – from myopic monks on magic mushrooms to superhuman detail

Manuscript tourism became a popular activity for wealthy scholars like Sir Robert Cotton (1571-1631), whose collection became the core of the British Museum’s collection.
Of course, many of these collectors simply stole or smuggled what they wanted from struggling monasteries in what are now Greece, Sinai and Israel.
But their work made possible the rise of printed editions of classical and medieval works.
Our modern editions of the Bible and the Iliad, for example, do not exactly match their underlying manuscripts.

Read more:
Dogs in the middle ages: what medieval writing tells us about our ancestors’ pets

Digital decay

Even if we prefer the edited versions, printed books decay faster than manuscripts, and take up just as much space.
Print does not solve the problem of preservation; it only postpones it.
In the 20th century, digital scanning tools and computer-based storage seemed to offer a new kind of solution.

Second, digital images are often in proprietary formats, meaning that without the library’s viewing software you cannot actually examine the manuscript.
The digital format is still chained to its digital shelves in a private space.
Third, as a recent cyber-attack on the British Library demonstrates, the digital space seems not to be safer than the physical one.
The digital library space, with its proprietary viewing software and its specialised file formats, is now shuttered.

Conservation and accessibility

Yet physical conservation comes at the expense of accessibility.
We can, however, use advances in AI and computer technology to improve approaches to digital conservation and enable wider access to the uniqueness of individual manuscripts.
To avoid digital decay, we need to devote the same attention to digital conservation as to material conservation.

Images of manuscripts would then have a readable text and all the unique elements of the material original – its decorations and artistry, its errors and doodles.
In this enhanced digital form, manuscripts could come to local museums, libraries and galleries, where they would be accessible to everyday visitors as well as specialists.
But unlike him, we can now offer the experience of the manuscript as well as the text, and to a much wider audience.

Jonathan L. Zecher receives funding from the Templeton Religion Trust.