International collaboration enhanced with increased GMP inspections

With the increasing need for improved global regulatory control, there has also been an increase in the international sharing of information between global authorities. Recently, the US American Health Agency FDA had informed the Swiss Authority Swissmedic regarding the concerns raised over GMP violations by, the Indian drug manufacturers.

This makes it more important for the drug manufacturing companies to prove that they have complied with the GMP standards and ensured the quality of their products including the imported APIs and medicinal substances and that of their finished products manufactured from the imported substances.

It is expected that the German BfArM and the Swissmedic would also share their information more closely. Recently, these two bodies signed a declaration of intent with an aim to promote the exchange of information and enhance sharing about each other’s regulatory requirements. The European EMA has also started issuing GMP Non-Compliance Statements and entering them in the EudraGMDP database for the purpose of sharing information to all EU Member States. Also, the companies receiving a Non-Compliance Statement are no longer allowed to market their products.