Zierenberg O
MSD Sharp & Dohme GmbH, Haar.
Z Arztl Fortbild Qualitatssich. 1997 Nov;91(7):596-600.
The research-based pharmaceutical industry supports the European harmonization process for the granting of pharmaceutical registrations. In order to improve consumer protection and the therapeutic options available to physicians in comparison to nationally registered products, the harmonization must be carried out on schedule and transparently a high scientific standard. It must not lead to the adoption of all national restrictions regarding data sheets and patient leaflets. Pharmaceutical products with the same ingredients can be registered either through the national or through the European procedure. This situation can only be remedied by the harmonization of core SPCs. This process must be agreed in consultation between pharmaceutical companies and regulatory authorities. With regard to measures to avert drug risks, professional associations and the pharmaceutical companies affected should be heard by the national authorities and their arguments given due consideration. In addition, national authorities and the CPMP must coordinate their decisions before they are published. In particular, the basis of these decisions should be made clear and therapeutic alternatives should be known.
以研究为基础的制药行业支持药品注册的欧洲协调进程。为了与国家注册产品相比，提高消费者保护水平以及医生可获得的治疗选择，协调必须按时、透明地以高科学标准进行。它不得导致采用所有关于数据表和患者说明书的国家限制。具有相同成分的药品可以通过国家程序或欧洲程序进行注册。这种情况只能通过核心药品说明书的协调来补救。这一过程必须在制药公司和监管当局之间的协商中达成一致。关于避免药物风险的措施，国家当局应听取专业协会和受影响的制药公司的意见，并对其论点给予应有的考虑。此外，国家当局和人用药品委员会在发布决定之前必须协调他们的决定。特别是，这些决定的依据应该明确，治疗替代方案应该为人所知。
