Pharmaceutical Technology - September 2021


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46 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 P h a r m T e c h . c o m Industry Perspectives I n November 2020, the European Commission (EC) published its Pharmaceutical Strategy for Europe, which comprises four main objectives: affordable medicines access; support of the European Union's pharma industry's competitiveness, innovation, and sus- tainability; boosting crisis preparedness and response; and strengthen- ing the EU's global position in pharma (1). "The Pharmaceutical Strategy addresses affordability, access to and shortages of medicines, and support for innovation across the EU pharmaceutical industry. It covers the full lifecycle of a medicine and is designed to take into account the latest scientific trends and digital technologies—such as advances in biotechnology and the use of arti- ficial intelligence (AI)," confirms Gabriela Marton, director of Regula- tory Affairs at Arriello. "Proposed revisions to the basic pharmaceutical acts are expected in late 2022, for example, Directive 2001/83/EC and Regulation (EC) No 726/2004. There is a wider goal too, which is to strengthen the role of the European Medicines Agency (EMA)." Di- rective 2001/83/EC and Regulation (EC) No 726/2004 are the primary legislations that set out the requirements and procedures for marketing authorization in the EU (2,3). In a summary of the strategy, Peter Gough, vice-president, Pharma- ceutical Services, EMEA, NSF Health Sciences, confirmed that a main topic covered by the commission is to meet unmet medical needs and ensure that medicines are accessible and affordable (4). To meet these goals, Gough revealed that the commission is seeking to tailor incentives to stimulate innovation in areas of unmet medical need, revise legisla- tion on pediatric and rare diseases medications, address antimicrobial resistance by incentivizing the development of novel antimicrobials, and Mapping Out Pharma's Future Felicity Thomas There are expectations that changes to pharma regulations in the EU, forming part of the regions broader strategy for the industry, will be positive and should offer flexibility for industry to advance through innovation. MARTINA - STOCK.ADOBE.COM

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