Quo vadis Regulatory Affairs?

Rubrik: europharm

(Treffer aus pharmind, Nr. 01, Seite 61 (2016))

Sickmüller B | Brinker A | Ginnow B | Hauk S | Hirt C | Hornberger A | Koop H | Melzer M | Reinecke K | Wallmann S | Wilken M

Quo vadis Regulatory Affairs? / 50 Years of Pharmaceutical Legislation in the EU: An overview from the Past to Present and the Future – Part 2 * Part 1 see Pharm. Ind. 2015;77(12): 1724–1730 · Sickmüller B, Brinker A, Ginnow B, Hauk S, Hirt C, Hornberger A, Koop H, Melzer M, Reinecke K, Wallmann S, Wilken M · ¹German Pharmaceutical Industry Association (BPI e. V.) und ²Brinker Pharma GmbH und ³PharmaLex GmbH und ⁴Extedo GmbH und ⁵Ursapharm Arzneimittel GmbH und ⁶Chibret Pharmazeutische GmbH und ⁷Almirall Hermal GmbH und ⁸Desitin Arzneimittel GmbH und ⁹Dr. Kade Pharmazeutische Fabrik GmbH
Close cooperation with the relevant areas in a company is extremely important. Below major activities for cooperation are described. The German Act on the Reform of the Market for Medicinal Products (AMNOG) came into force on 01 Jan 2011 in Germany [ 15 ]. It completely revises pricing regulations for newly authorized pharmaceuticals and their reimbursement by statutory health insurance providers. For the first time in Germany, pharmaceutical companies are obliged to submit a dossier on product benefit when a product with a new chemical entity (NCE) is launched on the German market or authorized for new indications with regulatory data protection ...

Quo vadis Regulatory Affairs?

Rubrik: europharm

(Treffer aus pharmind, Nr. 12, Seite 1724 (2015))

Sickmüller B | Brinker A | Ginnow B | Hauk S | Hirt C | Hornberger A | Koop H | Melzer M | Reinecke K | Wallmann S | Wilken M

Quo vadis Regulatory Affairs? / 50 Years of Pharmaceutical Legislation in the EU: An overview from the past to the present and the future – Part 1 · Sickmüller B, Brinker A, Ginnow B, Hauk S, Hirt C, Hornberger A, Koop H, Melzer M, Reinecke K, Wallmann S, Wilken M · ¹German Pharmaceutical Industry Association (BPI e. V.) und ²Brinker Pharma GmbH und ³PharmaLex GmbH und ⁴Extedo GmbH und ⁵Ursapharm Arzneimittel GmbH und ⁶Chibret Pharmazeutische GmbH und ⁷Almirall Hermal GmbH und ⁸Desitin Arzneimittel GmbH und ⁹Dr. Kade Pharmazeutische Fabrik GmbH
In the European Union (EU) the first standards for Quality, Safety and Efficacy of medicinal products for human use were established in the years 1965 and 1975 by Directives 65/65/EEC (Basic Directive with 12 pages and 25 articles) [1], 75/318/EEC (Standards for Testing) [2] and 75/319/EEC (introducing the Committee for Proprietary Medicinal Products – CPMP) [3]. These directives set the basis for key principles that are still valid today to guarantee the quality, safety and efficacy of medicinal products. The first edition of the Notice to Applicants – NtA (Vol 2 in the series “The Rules governing medicinal Products in the European Community – ...