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, 15 January 2025:
The PIC/S Committee has granted the status of Associated Partner Organisation to the African Union Development Agency - New Partnership for Africa's Development (AUDA-NEPAD).
MoreWith a shared dedication to safeguarding public health and safety, PIC/S and AUDA-NEPAD have decided to establish a cooperation agreement in the field of Good Manufacturing Practice (GMP) standards and quality systems for pharmaceutical products and Active Pharmaceutical Ingredients (API).
The scope of the cooperation agreement includes :
With the active contribution of other stakeholders, collaboration activities will aim at supporting capacity and confidence building among African NRA and at guiding them on their journey toward becoming PIC/S Participating Authorities.
The agreement is also a great opportunity for both partners to develop exchanges of information and share experiences.
This partnership reflects PIC/S commitment to strengthening global harmonization and cooperation in the field of GMP.
We look forward to working closely with our partners and stakeholders to achieve these goals and foster a more robust regulatory environment worldwide.
An official welcome will be given to AUDA-NEPAD at the next PIC/S Committee meeting, which will take place in Geneva on 14 and 15 April 2025.
Geneva, 8 January 2025:
The Department of Health and the Pharmacy and Poisons Board of Hong Kong are pleased to host the 2025 PIC/S Seminar on “Advanced technologies in pharmaceutical manufacturing” in Hong Kong (Hong Kong SAR, China) from 5-7 November 2025, preceded by the PIC/S Committee meeting.
The Seminar is the main annual international training event by PIC/S which is open to GMP Inspectors from PIC/S Participating Authorities, (Pre-)Applicants, Partners and non-PIC/S Member Medicines Regulatory Authorities.
Geneva, 6 January 2025:
It is with great sadness that we share the news of the passing of our esteemed colleague Boon Meow Hoe.
Boon was an emblematic figure of PIC/S for more than 25 years, occupying various positions in our structure, as Chair of course, but also as a member of the Executive Bureau.
He played a key role in the creation of the PIC/S Inspection Academy (PIA), which he continued to support in his role as Chair of the Subcommittee on Training. His imprint on our family is indelible.
Boon's passing is a terrible loss both on a human and professional level and we can only bow before his memory. We will all remember a smiling, courteous, efficient Man, always ready to find solutions. He gave his all for his country but also for us with a vision that was always present to ensure the development and sustainability of PIC/S. He always worked with the same target of ensuring protection of Public Health.
May he rest in peace and live on in our memories, for ever.
Our deepest condolences to his Family and to the Health Sciences Authority of Singapore (HSA).
Geneva, 13 December 2024:
PIC/S has published the following two guidance documents for inspectors: "Guidance on Remote Assessments" (PI 056-1) and "Aide Memoire on Remote Assessments" (PI 057-1). These documents have been prepared by the PIC/S Working Group on Remote Assessment, led by Jenny Hantzinikolas (Australia / TGA), and will enter into force on 1 January 2025. They are available for downloading on the page "Publications".
Geneva, 20 November 2024:
PIC/S is pleased to announce that in May 2024 it has been awarded a 3-year grant from the Bill & Melinda Gates Foundation.
MoreThis funding will provide PIC/S with the necessary resources to further its mission to improve public health by leading development and implementation of inspection frameworks for human and veterinary medicines through harmonisation of standards and offering world class training to regulatory inspectors around the globe.
The PIC/S project workstreams supported by this grant will aim at strengthening regulatory inspection standards to facilitate improved access to quality medicines in African countries by preparing a number of African National Regulatory Authorities for entry into PIC/S - through the PIC/S pre-accession process - as well as foster exchanges and co-operation between PIC/S, the upcoming African Medicines Agency (AMA) and its related members.
PIC/S looks forward to the possibilities that this grant will bring and to the impact it will have globally thanks to the support of the Bill & Melinda Gates Foundation.