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Regulatory Newsletters

Regulatory Newsletters

  • CTIS Highlights issue 5 published
  • Start of pilot program of the EMA-FDA parallel scientific advise for hybrid/ complex generic
  • "Human Medicines Highlights" EMA Newsletter - October 2021 issue
  • Launch of GMP inspection management in IRIS
  • Deadline extension to register for (new) sites for Medicinal Products during MAA and variations (IA,IB,II) in Organisation Management Service (OMS) : new mandatory deadline of 1 November 2021
  • EMA's SME office report 2016-2020
  • Guidance on applying in parallel with an EU marketing authorisation application
  • EMA public statement on additional measures to allow experts to focus on COVID-19 activities

EUROPHARM SMC

12 Allee de la Recherche

B-1070 Brussels

info@europharmsmc.org

+32 477 46 90 74

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About Europharm SMC

Europharm SMC is the European Pharmaceutical Association representing Small and Medium Sized pharmaceutical Companies. Europharm's mission is to support and defend the interests of SMEs and is a unique business network of pharmaceutical SMEs coming from all European countries

@ Europharm SMC 2021. All Rights Reserved.