Timón M
Biological Products, Advanced Therapies and Biotechnology Division, Agencia Española de Medicamentos y Productos Sanitarios, Campezo 1, 28022 Madrid, Spain.
Allergol Immunopathol (Madr). 2017 Dec;45 Suppl 1:1-3. doi: 10.1016/j.aller.2017.09.001. Epub 2017 Nov 3.
Allergen medicinal products in the European Union are regulated differently across the different Member States. Thus, whereas in some countries strict quality, safety and efficacy requirements are in place, in others, most allergens are on the market as Named Patient Products, without any regulatory oversight. This situation results on European allergic patients being exposed to totally different standards depending on where they live. Initiatives to correct this situation are needed.
欧盟各国对变应原药物产品的监管方式各不相同。因此，在一些国家，严格的质量、安全和有效性要求已经到位，而在其他国家，大多数变应原作为指定患者产品投放市场，没有任何监管。这种情况导致欧洲过敏患者根据其居住地点面临完全不同的标准。需要采取措施纠正这种情况。
