The European Confederation of Pharmaceutical Entrepreneurs (Eucope) – whose members include mid-sized pharmas like Biogen Idec as well as developers of orphan drugs – was one of several organisations to warn the EC that the new requirements could cause active pharmaceutical (API) shortages.
But, despite DG-Sanco’s response in which it pledge to take such concerns into account and the EC’s recent decision to waive the ‘written confirmation’ requirement for US made APIs, some Eucope members still have concerns says spokesman Oliver Sude.
He told in-Pharmatechnologist.com that: “While for most of our members the EC’s decision to grant US-based API manufacturers exemption was the most important thing, some companies do import from India and China where there are still a lot of open issues.”
Sude added that the EC had initially 'underestimated' the challenge involved in asking non-EU regulators to make sure their API manufacturers meet quality requirements and overestimated the role European drugmakers could be able to play in bringing this about.
“Industry cannot be expected to be solely responsible for pushing foreign governments into undertaking the necessary inspections” he said, adding that “the EC has recognised this in the last six months and pushed on a political level” citing India and China as countries in which some important steps forward have been achieved.
The new API import rules – including the written confirmation requirement – came into effect today, meaning that drug actives will not be allowed into the European Union (EU) if they lack the necessary documentation.
The only exceptions to this are APIs made in Australia, Japan, Switzerland and the US, where quality systems and standards have been deemed as being equivalent to those in place in the European Union.
According to recent comments by the European Medicines Agency (EMA) the majority of the APIs used in the EU are made in India and China.
In January, Chinese authorities asked API manufacturers to provide copies of good manufacturing practices (GMP) compliance certificates citing the new EU laws as a motivation, and last month Indian authorities published a list of the API facilities that have been inspected and issued with written confirmations of quality.