The UK MHRA says regulators Europe-wide are asking drugmakers for additional data to identify plants that need to be inspected under new EU API import rules.
From July active pharmaceutical ingredients (API) shipped to the European Union will need to be accompanied written confirmation from local regulators that they were produced to standards equivalent to European good manufacturing practices (GMP).
The UK Medicines and Healthcare products Regulatory Agency (MHRA) told in-Pharmatechnologist.com it is “asking all authorised manufacturers of medicinal products for human use in the UK questions relating to imported active substances used at their authorised site.”
It went on to say that other national authorities are asking the same questions of marketing authorisation (MA) holder based in their countries and added that drug companies in the UK have been given until January 16 to provide the requested information.
The MHRA is asking:
Does your site use active substances which have been manufactured outside the EEA and have been imported into the Union?
What is the name and address of the active substance manufacturer?
Does the active substance manufacturer hold a valid EEA GMP certificate and or is this active substance named on the GMP certificate?
In which country is the Competent Authority which issued the GMP certificate located?
The MHRA explained that: “The resulting active substance data set will be collated with that obtained by EMA for centrally authorised products to give a list of active substance manufacturers in third countries that may need to be inspected in order to minimise the potential risk of shortages due to the incoming rules on importation of active substances.”
The comments come just a few weeks after the MHRA warned the new EU laws may require it to inspect as many as 1,200 API manufacturing sites , which prompted concerns that it lacked sufficient capacity to conduct these assessments.