EU, Japanese Regulators Launch Expanded GMP Mutual Recognition System

Posted 07 October 2013 | By Alexander Gaffney, RAC 

EU and Japanese regulators are for the first time beginning to share good manufacturing practice (GMP) data between one another in limited cases, the European Medicines Agency (EMA) announced on Monday (7 October 2013).

At present, most global regulators receive data regarding not just the drug product for which a company seeks approval, but information on the way in which it will be manufactured as well. Regulators generally take that information and use it to assess the manufacturing facility's adherence to GMPs and if the product can be manufactured at scale.

But those inspections can end up being extremely repetitive, particularly for companies whose products are approved and marketed throughout the world. Focus has spoken with some industry regulatory officials who have reported having at least one inspection per month on average throughout some years.

In recognition of this challenge, some regulators have initiated discussion around so-called "mutual recognition agreements," or MRAs. In principle, the agreements allow a regulator to rely on the findings of another inspection regime (e.g. EMA relying on the US Food and Drug Administration), allowing them to have reasonable assurances of GMPs being followed. In addition, regulators are then able to inspect other facilities they might otherwise not have the regulatory capacity to get to.

Now EMA and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) have announced the expansion of its MRA with Japan to include GMP data "related to Japanese manufacturers upon the manufacturer's request."

The first EMA-PMDA MRA was put into effect in 2004, according to documents maintained on EMA's website, and the latest announcement serves to expand the existing MRA.

"It allows the EMA, European national competent authorities and Japanese authorities to use information in EudraGMDP instead of issuing original paper GMP certificates for a number of regulatory procedures, such as marketing authorisation applications or variation applications, including the addition of a new manufacturer," EMA wrote. "The EU and Japanese regulatory authorities will now accept a reference to a EudraGMDP entry, or a downloadable file or print-out from the database, within the scope of the EU-Japan MRA."

If the digital information is not accessible through the EudraGMDP system, paper copies may still be requested from members of industry, EMA added.

EMA Statement

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