Procedural advice on paediatric applications
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Procedural advice on paediatric applications
Key Points:
- 9 Human Medicines Division Procedural advice on paediatric applications Guidance for applicants 1 1 To be consulted together with the IRIS guide for applicants.
- Placing paediatric medicines on the market ......................................................... 15 Procedural advice on paediatric applications EMA/672643/2017 Rev.
- Regulation (EC) No 1901/2006 (the 'Paediatric Regulation') lays down obligations, rewards and incentives for the development and placing on the market of medicines for use in children.
- Where results of paediatric studies are submitted, applicants should include in the clinical overview a rationale supporting the proposed changes to the Product Information.
- Further information can be found in the Procedural Advice document on ?applications for PIPs, Waivers and Modifications.
- However, the following types of application are exempted from the application of the above requirements: Procedural advice on paediatric applications EMA/672643/2017 Rev.
- Objectives The Paediatric Regulation came into force in the European Union (EU) on 26 January 2007.
- Its main impact was the establishment of the Paediatric Committee (PDCO), which is responsible for coordinating the Agency's work on medicines for children.
- For pre-submission interactions: Send a question to the European Medicines Agency Procedural advice on paediatric applications EMA/672643/2017 Rev.
- for modification of a paediatric investigation plan) it is suggested to record all successive name changes in the document.? Invented name: The trade name of a medicine.
- In general paediatric investigation plans should be submitted early during product development, in time for studies to be conducted in the paediatric population, where appropriate, before marketing authorisation applications are submitted.
- It is often referred to as full waiver as it is related the age range covering all paediatric subsets.
- During the second PDCO discussion, either a request for modification (RfM) or PDCO opinion is adopted: Procedural advice on paediatric applications EMA/672643/2017 Rev.
- Opinion According to Article 25(1) of the Paediatric Regulation (Regulation (EC) No 1901/2006), within ten days of its receipt, the Agency shall transmit the opinion of the Paediatric Committee to the applicant.
- The following documents should be uploaded into ?Documents from applicant? in addition to the IRIS application for the related initial PIP: ? Detailed grounds for re-examination in a Word document Procedural advice on paediatric applications EMA/672643/2017 Rev.
- EMA decision According to Article 25(5) of the Paediatric Regulation (Regulation (EC) No 1901/2006), the Agency issues its decision within 10 days of the Paediatric Committee's definitive opinion.
- The following documents should be uploaded into ?Documents from applicant? in addition to the IRIS application for Discontinuation of paediatric development: Procedural advice on paediatric applications EMA/672643/2017 Rev.
- See also: Deadlines for placing paediatric medicines on the market Procedural advice on paediatric applications EMA/672643/2017 Rev.