This year, with annual sales of nearly 400 million of raw material medicine enterprise a company receives the MHRA (United Kingdom medicines and healthcare products regulatory agency) issued a certificate of EU-GMP, 3 products which means that it will be in the form of API access to the EU market.
Previously, in June 2011, the European Parliament and the European Commission issued new instructions, 2011/62/EU, from July 2, 2013, all imports of human activity (AS) written certification must be issued by the exporting country regulators.
According to the European generic medicines Association estimates that EU 75% of raw materials from outside the European Union, of which about 20% from China.
July 11-12th in Beijing organized by the EU-China seminar on pharmaceutical quality regulations, as on the agenda of the 62nd EU directive is clear.
In accordance with the EU directive on the new interpretation, even though he had access to EU GMP certified API enterprise, such as a company, and also SFDA (State food and Drug Administration) issue a written certification.