Faculdade de Farmácia, Universidade de Lisboa.
PDA J Pharm Sci Technol. 2020 Nov-Dec;74(6):617-626. doi: 10.5731/pdajpst.2020.011437. Epub 2020 Jun 15.
The pharmaceutical industry is one of the most competitive sectors in Europe and has a strong presence in many European Union (EU) countries. The mutual recognition agreement (MRA) for inspections of medicines manufacturers between the United States (US) Food and Drug Administration (FDA) and the EU started by the end of 2017 and gradually extended to all EU member states (MSs) in July 2019. We quantified the number of FDA and EU good manufacturing practice (GMP) inspections carried out in each other's territory between 2009 and 2018. The five EU MSs with the largest number of FDA inspections were Germany, followed by Italy, France, the United Kingdom (UK), and Spain. All of them, with the exception of Germany, were included in the group of the first eight EU MSs recognized by the FDA in the context of the MRA. In 2018, these five EU MSs were within the top 10 EU exporters of pharmaceutical products to the US. Four of these five EU MSs (Italy, Germany, France, and the UK) accounted for 53.4% of the total pharmaceutical production in the EU in 2018. We also studied the type of manufacturing operations covered by the manufacturer's authorizations issued by each EU MS for the manufacturers within its territory. We verified a high prevalence of conventional technology versus complex technology manufacturing for many EU countries. Going forward, this unbalance should be addressed at a national and EU level. Supporting for instance (bio)pharmaceutical manufacturing through pharma policy initiatives, especially for EU countries with a lower level of innovation and technological development, would promote the pharmaceutical manufacturing sustainability and competitiveness of these countries. The full implementation of the MRA between the US FDA and the EU can make it faster and less costly for both sides to bring medicines to the market, improving future competitiveness of the EU and the US pharmaceutical industry.
制药业是欧洲最具竞争力的行业之一，在许多欧盟（EU）国家都有很强的存在感。美国（US）食品和药物管理局（FDA）与欧盟之间的药品制造商检查互认协议（MRA）于 2017 年底开始，并于 2019 年 7 月逐步扩大到所有欧盟成员国（MSs）。我们量化了 2009 年至 2018 年期间在美国和欧盟进行的 FDA 和欧盟良好生产规范（GMP）检查的数量。接受 FDA 检查数量最多的五个欧盟 MS 是德国，其次是意大利、法国、英国（UK）和西班牙。除德国外，其余四个国家都在 MRA 背景下被 FDA 认可为首批八个欧盟 MS 之列。2018 年，这五个欧盟 MS 是向美国出口药品的欧盟前 10 大出口国之一。在这五个欧盟 MS 中，有四个（意大利、德国、法国和英国）占 2018 年欧盟制药总产量的 53.4%。我们还研究了每个欧盟 MS 为其境内制造商颁发的制造商授权所涵盖的制造操作类型。我们发现，对于许多欧盟国家，常规技术与复杂技术制造的比例很高。未来，这一不平衡状况应在国家和欧盟层面得到解决。例如，通过制药政策举措支持（生物）制药制造，特别是对创新和技术发展水平较低的欧盟国家，将促进这些国家的制药制造可持续性和竞争力。美国 FDA 与欧盟之间 MRA 的全面实施可以使双方更快、更经济地将药品推向市场，提高欧盟和美国制药业的未来竞争力。
