Regulatory News

Counter-Espionage Law: Do GMP inspectors no longer go to China?

As we reported at the end of last year, China has revised its counter-espionage law. Now there are fears that this will also affect GMP inspections and audits, as the German Handelsblatt writes.

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FDA Warning Letter: Missing Stability Studies

In December 2023, the U.S. FDA issued a Warning Letter (WL) to the US American company "Inopak, Ltd." after having inspected its site in July and August 2023. According to U.S. FDA Warning Letter, the firm failed to maintain an ongoing stability program for their drug product.

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EU and MHRA extend GMP and GDP Certificates

The validity of EU GMP and GDP certificates is to remain in place until 2024 or until the completion of the next on-site inspection, whichever comes first. Until then, supervision will be performed risk-based.

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EU Commission: Strategy Paper with Measures against Medicine Supply Shortages

The European Commission has adopted a package of measures to prevent and mitigate shortages of critical medicines in the EU in the near future. This "set of actions" now presented complements the reform of the pharmaceutical legislation.

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Ozempic Falsifications: BfArM starts Investigation

The German Federal Institute for Drugs and Medical Devices (BfArM) has taken over coordination in the case of the counterfeit diabetes drug Ozempic®, as several German states are now actively involved in the case. The agency advises all pharmaceutical companies, wholesalers as well as pharmacies to check all packages of the drug Ozempic® with utmost care.

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EMA: Q&As on the Topic of "Parallel Distribution" updated

Once again, the "Frequently asked questions about parallel distribution" have been revised and published on the EMA website. The information provided by the EMA on parallel distribution of centrally authorised medicinal products is set out in the Q&A in six paragraphs.

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The possible Impact of Artificial Intelligence on the Role of the Qualified Person

Artificial intelligence (AI) is revolutionising industry, and the pharmaceutical sector is no exception. One might think AI reaches its limits when it comes to GMP. But there are promising possibilities.

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EU-GMP Chapter 7: Is a "Chain of Contracts" allowed?

The EMA has updated its Questions and Answers and discusses where and when "Chain of Contracts" are accepted and which principles should be adhered to.

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EU-GMP: Is remote QP Batch Certification/Confirmation allowed?

The EMA has published new questions and answers on remote batch certification/ confirmation by the Qualified Person (QP). When allowed by the competent authority, clear expectations are defined.

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COVID-19 Flexibilities also to be terminated in the GMP/GDP Environment

The EU is phasing out the extraordinary regulatory flexibilities for medicines that were put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic. This includes regulatory procedures, manufacturing and importation of APIs and finished products and other requirements.

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