What are the current GMP Inspection Initiatives?

The International Coalition of Medicines Regulatory Authorities (ICMRA) has published a very interesting overview about the current global GMP inspection initiatives by the competent authorities. It also shows the various initiatives between the EU and the US Food and Drug Administration (FDA):

EMA/FDA/TGA API Programme

This programme of the European Medicines Agency (EMA), the European Directorate of the Quality of Medicines and Healthcare (EDQM), the European National Supervisory Authorities, the US Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA) and the World Health Organization (WHO) tries to foster the cooperation and mutual confidence between the participants through better communication and exchange of information on inspection planning. It covers joint inspections of API manufacturers located outside the participating regions but also the reliance on API inspections by other authorities.

EMA/FDA Mutual reliance Confidence building

The overall objective of this initiative is to allow some inspections on each others' territories to be deferred or waived completely based on a number of considerations.

EMA/FDA Finished Products programme

This programme is closely related to the one above. Here, EMA and FDA are evaluating whether greater international collaboration can help to better distribute inspection capacity, allowing more sites to be monitored and reducing unnecessary duplication, limited to inspections of manufacturers of human medicinal (finished drug) products which come under the authority of FDA's Center for Drug Evaluation and Research and the centralised marketing authorisation process in the EU.

PIC/S Pharmaceutical Inspection Co-operation Scheme

Inspectorates from various EU Member States and the FDA are member of PIC/S which tries to foster the international co-operation in the field of GMP by developing and promoting harmonised GMP standards and guidance documents, training GMP inspectors, assessing (and reassessing) GMP inspectorates and facilitating co-operation and networking and planning of inspection.

The International Coalition of Medicines Regulatory Authorities (ICMRA) is a voluntary, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities that work together to

  • address current and emerging human medicine regulatory and safety challenges globally, strategically and in an ongoing, transparent, authoritative and institutional manner
  • provide direction for areas and activities common to many regulatory authorities' missions
  • identify areas for potential synergies
  • wherever possible, leverage existing initiatives/enablers and resources

ICMRA wants to provide a global architecture to support enhanced communication, information sharing, crisis response and address regulatory science issues.

The overview is available as ICMRA - Mapping of GMP Inspection Initiatives

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