IPEC e-newsletter - Excipients Insight October 2017 - 16-10-17


Inside this issue


New EU GMP Directive separates finished and investigational medicines

The European Commission has published a new Directive on the principles and guidelines of good manufacturing practice for human-use medicinal products, which updates Directive 2003/94 and is due to come into effect on 31 March 2018.

Directive 2017/1572 was published on 15 September in the Official Journal of the European Union, with a delegated regulation Directive 2017/1569 published on the following day which sets out GMP guidelines for investigational medicinal products (IMPs).

Previously, IMPs were covered under 2003/94 along with licensed products and the intention is to separate these out into different documents for clarity and flexibility.

The EC carried out a public consultation two years ago to get feedback on the plans separate GMP for marketed and investigational drugs, saying that because GMP for IMPs “already exists and is generally well-functioning, there is no need to reinvent the wheel.”

Aside from solving the issue of deleting references to IMPs, Directive 2017/1572 also includes some updates to the definition of a pharmaceutical quality system and some terminology amendments “to reflect the international developments or the actual usage of that terminology of inspectors and manufacturers.”

A commentary on the changes by pharmaceutical GMP and quality management trainer Dominic Parry of Inspired Pharma Training notes that the 2017/1572 has an almost identical structure to the directive it replaces and maintains many of the same requirements.

There are a few changes, including updates to Article 3 - Inspection aimed at manufacturers of Advanced Therapy Medicinal Products (ATMPs) such as cell or gene therapies, which also now refers to a requirement for regulators to also operate within a formal quality system.

Meanwhile, the European Compliance Academy (ECA) notes that 2017/1569 also regulates the responsibilities of qualified persons (QPs) in the context of EU regulations on Good Clinical Practice (GCP), and describes the different requirements for IMPs manufactured within and outside EU member states.

Directive 2017/1572 has to be converted into national law, and member states are asked to adopt and publish the new legislation by March 31, 2018




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