Geneva, 19 October 2020:
On 24 September 2020 a webinar meeting of the PIC/S Expert Circle on Quality Risk Management (QRM), was hosted by the Turkish Medicines and Medical Devices Agency (TMMDA).
This PIC/S Expert Circle, currently chaired by Ireland / HPRA, has been active in developing and running advanced QRM training for GMP Inspectors for several years now to enable them to more effectively inspect the application of risk assessment and QRM during inspections in a harmonised manner. It also enables Inspectors to effectively use the PIC/S Recommendation in relation to risk-based GMP inspection planning (PI 037-1).
This webinar, which included some training aspects, was solely for GMP inspectors, and allowed to discuss updates and progress on applicable QRM guidance.
In particular, it led to important developments on:
The webinar was attended by more than 200 inspectors from more than 50 countries / entities, including PIC/S Members, (Pre-)Applicants, Partners as well as a large number of non-PIC/S Member Medicines Regulatory Authorities, namely from Chad, Congo, Gambia, Ghana, India, Kenya, Libya, Malawi, Namibia, Philippines, Russian Federation, Sierra Leone, Somaliland, Sri Lanka, Tanzania, Tunisia, Uganda, Yemen, Zambia and Zimbabwe.
For some of these non-Members, in particular from Africa, this was the first time they were attending a PIC/S event.
In addition to its Members (53), Applicants (4), Pre-Applicants (4) and Partners (EDQM, EMA, OIE, UNICEF and WHO), PIC/S as a global organisation very much welcomes interest and opportunities for engagement with non-Member Medicines Regulatory Authorities, even if they are not yet ready to submit a PIC/S accession or pre-accession application.
This also underlines the importance of one of PIC/S most important projects, the PIC/S Inspectorates’ Academy, which is a Global Capacity and Training Initiative aiming at delivering inspection excellence through harmonised training in the field of GMP to ensure that high quality standards for medicinal products are met worldwide in the interest of public health.
For these reasons, the recording of this webinar will be made available via the PIC/S Inspectorates’ Academy to any interested non-Member Medicines Regulatory Authorities. This will include French and Portuguese language versions thanks to the good works of Oakes Group Global and their Africa-wide PIC/S Initiative (AwPI) efforts. AwPI is an initiative independent from PIC/S that is promoting PIC/S with non-Member authorities in Africa and will be making possible the translation to French and Portuguese. Information will be posted on the PIC/S website once this is available for non-Member Medicines Regulatory Authorities.
Geneva, 12 February 2026:
The joint EMA - PIC/S drafting group has developed a concept paper on the revision of the Annex 6 (Manufacture of medicinal gases) of the EU-PIC/S GMP Guide.
This concept paper aims to outline the rationale, objectives, and proposed changes for updating the Annex 6 - Manufacture of medicinal gases, of the Good Manufacturing Practice (GMP) Guide, that is common to the Member States of the European Union (EU) / European Economic Area (EEA), as well as to the Participating Authorities (PAs) of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
The aim of the revision is to carry out a limited review and update of the guideline to reflect industry’s current practices, including the use of new technologies and computerized systems.
This concept paper is submitted to a joint EMA - PIC/S public consultation from 11 February 2026 until 11 April 2026 and can be downloaded on the PIC/S website (link) as well as on the EMA website (link).
Comments should be submitted via the EU Survey tool (link) in accordance with the PIC/S - EMA Harmonised Consultation Procedure.
Geneva, 10 February 2026:
The joint EMA - PIC/S drafting group has developed a concept paper on the revision of the Annex 15 (Qualification and validation) of the EU - PIC/S GMP Guide.
This concept paper aims to outline the rationale, objectives, and proposed changes for updating the Annex 15 - Qualification and validation, of the Good Manufacturing Practice (GMP) Guide, that is common to the Member States of the European Union (EU) / European Economic Area (EEA), as well as to the Participating Authorities (PAs) of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
The aim of the revision is to extend the scope of the annex to active substances manufacturers and to consider the revision of ICH Guideline Q9 (R1) on quality risk management.
This concept paper is submitted to a joint EMA - PIC/S public consultation from 9 February 2026 until 9 April 2026 and can be downloaded on the PIC/S website (link) as well as on the EMA website (link).
Comments should be submitted via the EU Survey tool (link) in accordance with the PIC/S - EMA Harmonised Consultation Procedure.
Geneva, 10 February 2026:
On 20 March 2025, Kazakhstan’s Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare of the Republic of Kazakhstan (“CMPC”) and the State Enterprise on the right of economic management “National center for expertise of medicines and medical devices” (“NCEM”) of the Committee applied for PIC/S membership.
The application request was confirmed as complete at the PIC/S Committee meeting in Hong Kong (Hong Kong SAR, China) on 3-4 November 2025, further to which a Rapporteur and Co-Rapporteur were appointed.
Geneva, 3 February 2026:
The Ghana Food and Drugs Authority has applied for PIC/S pre-accession.
The pre-accession process started on 4 November 2025 following the appointment of a Rapporteur, which marks the start of the pre-accession process under the revised PIC/S pre-accession procedure.
Geneva, 1 January 2026:
On 1 January 2026, the Jordan Food & Drug Administration (JFDA) became the 57th PIC/S Participating Authority.
JFDA submitted a complete membership application in January 2021, after successfully completing the pre-accession process. A paper assessment was carried out followed by an on-site assessment visit, which took place in April 2025. The Audit team recommended to the Committee to accept the PIC/S membership application of JFDA. After endorsement by the PIC/S Sub-Committee on Compliance (SCC), the PIC/S Committee then unanimously decided at its meeting in Hong Kong on 3-4 November 2025 on the participation of JFDA in PIC/S as of 1 January 2026.