Module 6

02/10/2024

Recommended References

• Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on Orphan Medicinal Products. Official Journal of the European Communities . • Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical su per iority’. Official Journal of the European Communities . • Communication from the Commission on Regulation (EC) No 141/2000 of the European Parliament and of the Council on orphan medicinal products (2003/C 178/02). Official Journal of the European Union. • Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Official Journal of the European Union. • EMA Paediatrics Investigational Plans Overview Webpages. Available from: https://www.ema.europa.eu/en/human-regulatory/research development/paediatric-medicines/paediatric-investigation-plans • EMA Guideline on the acceptability of names for human medicinal products processed through the centralised procedure. EMA/CHMP/287710/2014 – Rev 6. 22 May 2014 • FDA Electronic code of federal regulations, Subpart C, Designation of an Orphan Drug, Part 316; Orphan Drugs. Available From: https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/e-cfr-21-part-316-orphan-drug-orphan-drug-act 1983 • EMA CHMP Guidance (7 May 2018): Enhance early dialogue to facilitate accelerated assessment of priority medicines (PRIME), EMA/CHMP/57760/2015, Rev. 1: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/enhanced-early-dialogue facilitate-accelerated-assessment-priority-medicines-prime_en.pdf • EMA Guidance (07-May 2018): EMA guidance for applicants seeking access to PRIME scheme. EMA/191104/2015: https://www.ema.europa.eu/en/documents/other/european-medicines-agency-guidance-applicants-seeking-access-prime-scheme_en.pdf • EMA Support for early access overview webpages. Available from: https://www.ema.europa.eu/en/human-regulatory/overview/support early-access • EMA PRIME overview website: https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 1 – Develop and Shape the Brand

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MSc Module 6: Regulatory Strategy; From Development to the Market Place

Awareness of Maintaining and Extending the Brand through continued Product Development: Part 2

Vina Mistry

Independent Regulatory Consultant: Pharmistry Consulting Ltd

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in Regulatory Affairs

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