Access to EU or blocked by botanical APIs

The European Commission has adopted a regulation on the import of active pharmaceutical ingredients (2011 / 62 / EU) to prevent counterfeit pharmaceutical ingredients from entering the supply chain An important requirement of these rules is that the export of botanical APIs from countries outside the European Union to the European Union needs to provide written certification from the local regulatory authorities that their production base meets the corresponding EU standards, whether or not they have obtained the inspection and certification of EDQM or the regulatory authorities of EU Member States If "third countries" outside the EU can prove that their manufacturing and inspection standards are the same as those in Europe, they can claim exemption from this provision Since the promulgation of the regulation, only Switzerland and Israel have made such a request to the European Commission At present, the two countries are under evaluation If they do have GMP and monitoring regulations equivalent to EU standards, such requests will be accepted Countries that have obtained such import exemption will no longer be required to provide the aforesaid written certification when their products and equipment are transported to EU countries However, China and India are most in need of the application The two countries have the most widely used and imported botanical APIs in Europe The European drug administration is in communication with relevant agencies in China and India.