Quick Glance: Regulatory and Inspection Harmonization
Regulatory and Inspection Harmonization continues to gather speed. Following the successful US/EU MRA completed on 11 July this year, a new Pilot Program is planned for Inspection Harmonization of Medicinal Product Sterile Manufacture. This program is scheduled to run for approximately two years and will include the following competent authorities:
- Australia – Therapeutic Goods Administration (TGA)
- Canada – Health Canada (HC)
- EMA – European Medicine Agency
- France – Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM)
- Japan – Pharmaceuticals and Medical Devices Agency (PMDA)
- United Kingdom – Medicines and Healthcare products Regulatory Agency (MHRA)
- United States – Food and Drug Administration (FDA)
- World Health Organization (WHO)
The Scope includes chemical, and some biotech products (e.g., MABs), but specifically excludes vaccines, ATMPs, and plasma-derived. The pilot includes routine surveillance and for cause, but pre-approval audits inclusion is discretionary. The scope specifically intends to avoid duplicate routine surveillance audits.
Inspection Models facilitated within this Pilot Program include:
- Sole Inspection – reliance upon Inspection by other Authority (with or without extension)
- Joint Inspection – collaborative planning, Inspection, reporting, CAPA plan reviews
- Concurrent Inspection – two independent inspections at the same time, which will most likely have different scopes, with the expectation that the two independent teams will exchange information.
Given the potential global impact of the much-heralded upcoming EU Annex 1 update, this is a very interesting pilot program that will probably be implemented while Annex 1 “Manufacture of Sterile Medicinal Products” comes into operation.
One of the complications for this pilot program is the absence of harmonized regulations; effectively, each Competent Authority will rely on its regulatory framework with some references to PICs and WHO standards that align with the EU Annex 1.
All initiatives that move the industry towards harmonization are to be welcomed but spare a thought for the sites that will undergo Concurrent or Joint Inspections as part of this program!
About the Author:
John has more than 23 years of experience providing technical and consulting services in cGMP pharmaceutical and biotechnical environments. John is an experienced QP with several years’ experience releasing both commercial and clinical material to market. John is a Quality Systems SME. He understands FDA and EU regulations, regulatory guidance documents, and ICH guidelines and has applied the knowledge to develop risk based approaches for several applications. John has significant experience in GMP/ISO compliance auditing of manufacturing facilities and supply chain.