WHO prequalification encourages international collaboration and harmonization of standards for the manufacture, quality control, regulation and monitoring of medicines, vaccines and other health products. In order to promote and support these principles WHO prequalification participates as an observer in relevant international fora and has signed collaboration agreements with several organizations, agencies and national regulatory authorities.
In this context Inspection Services follows, participates and provides input to relevant working groups of the International Coalition of Medicines Regulatory Authorities (ICMRA). ICMRA is a voluntary, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities that work together to:
- address current and emerging medicine regulatory and safety challenges
- identify areas for potential synergies and collaboration
- support enhanced communication, information sharing, crisis response
- address regulatory science issues.
Inspection Services provides feedback and supports WHO prequalification's participation in the International Council for Harmonization (ICH) in matters relating to inspections and pharmaceuticals. ICH's mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. Harmonization is achieved through the development of ICH guidelines via a process of scientific consensus with regulatory and industry experts working side-by-side.
Inspection Services promotes mutual awareness and alignment on GMP policy approaches between national regulatory authorities/inspectorates and development of common guidelines applicable to regulators and industry. Inspection Services has signed a co-operation agreement with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and is an associated partner. PIC/S is a non-binding, informal co-operative arrangement between regulatory authorities in the field of good manufacturing practice (GMP) for medicinal products for human or veterinary use. The mission of PIC/S is to lead the international development, implementation and maintenance of harmonized GMP standards and quality systems of inspectorates for medicinal products.
The pharmaceutical environment is continuously evolving, and the supply chain is becoming more complex. With the increasing globalization of pharmaceutical manufacturing and distribution channels, regulatory authorities across the world need to cooperate in the overall interest of public health. Inspection Services has been participating in initiatives with partner organizations on GMP inspections, in order to optimizing use of inspections capacity, enabling more sites to be monitored and reducing unnecessary duplication.
More specifically, Inspection Services participates in a programme to rationalize GMP inspection of active pharmaceutical ingredient manufacturing sites at international level. The aim is to foster cooperation and mutual confidence between participating regulators through better communication and exchange of information on inspections. The programme facilitates sharing of information on inspection planning and outcomes, and organization of joint inspections for manufacturing sites of common interest, as well as enhancing national regulatory capacity and harmonization of inspectional standards. The following regulatory authorities participate in this programme: the Agence nationale de sécurité du médicament et des produits de santé (France); the Danish Medicines Agecy; Health Canada; the Health Products Regulatory Authority (HPRA); the Italian Medicines Agency (Italy); the Medicines and Healthcare products Regulatory Agency (UK); the Pharmaceuticals and Medical Devices Agency (Japan); the Therapeutic Goods Administration; the US Food and Drug Administration; the European Directorate for the Quality of Medicines & HealthCare; and the European Medicines Agency,
In December 2019, EMA launched a pilot programme to share information on GMP inspections of manufacturers of sterile medicines located outside the participating countries and to organize joint inspections of manufacturing sites of common interest. The products in scope include sterile medicines for human use of chemical origin and certain therapeutic biotechnology-derived products, such as monoclonal antibodies and recombinant proteins. Vaccines, cell and gene therapies and plasma-derived pharmaceuticals are currently out of the scope of this pilot. The pilot will last for a minimum of two years. After this period, participating authorities will assess the programme and determine the next steps. WHO Inspection Services, along with EMA, ANSM(France), MHRA (United Kingdom), FDA (U.S.A), TGA (Australia), Health Canada (Canada) and PMDA (Japan) participate in this pilot phase.
Further to these initiatives, WHO prequalification has signed confidentiality and collaboration agreements with several national regulatory authorities around the world in order to increase access to quality, safe, efficacious medicines, vaccines and health products and to harmonize understanding and implementation of regulatory standards. Inspection Services engages inspectors from Member States to participate in prequalification inspections to enhance collaboration and sharing of information.
Sharing expertise and knowledge
In addition to supporting international inspection activities and sharing of information, Inspection Services shares its expertise and knowledge with regulators through opportunities for hands-on training. These include
- rotational fellowships at WHO Headquarters in Geneva, Switzerland for inspectors of low- or middle-income countries
- participation as an observer in WHO inspections.
These initiatives offer benefits not only to regulators but also to WHO prequalification since participating regulators bring their own insights into regulatory issues and the problems that may be faced by manufacturers or quality control laboratories when seeking to attain prequalification. Furthermore, on returning to their own countries, these regulators continue to promote and support WHO prequalification.