Revision of PIC/S GMP Guide (PE 009-16)

Geneva, 1 February 2022: The PIC/S GMP Guide to Good Manufacturing Practice (GMP) for Medicinal Products has been revised to include:

• a revised Annex 13 on the Manufacture of Investigational Medicinal Products; and
• a new Annex 16 on the Certification by the Authorised Person and Batch Release

PIC/S Annex 13 has been revised based on EC Regulation No. 536/2014 on Clinical Trials, which will replace EU Annex 13. This is in line with the Co-operation Agreement between PIC/S and EMA, which provides that the PIC/S and EU GMP Guides should be harmonised with the aim of keeping GMP standards equivalent, thus facilitating the exchange and use of information concerning the manufacture of medicinal products.

PIC/S Annex 16 is a new annex to the PIC/S GMP Guide. Historically, PIC/S did not adapt EU Annex 16, when it was adopted as part of the EU GMP Guide. Initially, PIC/S considered this annex to be EU-specific and difficult to transpose for PIC/S purposes, in particular since the PIC/S GMP Guide is limited to the manufacture of medicinal products and not to import and distribution. Following a consultation of PIC/S Participating Authorities in 2017, it was agreed to make an attempt to transpose EU Annex 16, considering that a PIC/S adaptation could offer added benefit to better convey expectations associated with product release and further international harmonisation efforts in line with PIC/S’ mission to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of medicinal products. PIC/S also agreed that elements in Annex 16 related to imported medicinal products would be voluntary, dependent on national law.

Both Annexes were successfully approved by the PIC/S Committee by written procedure on 26 January 2022. The drafting / revision process has been successfully driven by the PIC/S Sub-Committee on the Harmonisation of GM(D)P (SCH), led by outgoing SCH Chair Paul Gustafson (Canada / ROEB) and incoming SCH Chair, Ian Jackson (UK / MHRA).

The revised GMP Guide (PE 009-16), with the revised Annex 13 and the new Annex 16, will enter into force on 1 February 2022. This coincides with the entry into force of Regulation No. 536/2014 on Clinical Trials replacing EU Annex 13. 

All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose Annexes 13 & 16 of the PIC/S GMP Guide into their own GMP Guides.

To download the revised GMP Guide (PE 009-16), please consult the page “Publications”.

2024 PIC/S Seminar (Brasilia, Brazil)

Geneva, 16 July 2024: Registrations for the 2024 PIC/S Seminar on "Annex I Unveiled: Shaping the Future of Sterility” (Brasilia, 6-8 November 2024) are now open (for Medicines Regulatory Authorities only).

Recruitment of New PIC/S Secretary / Executive Director

Geneva, 24 June 2024:

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an organisation between currently 56 health regulatory authorities from all over the world, which has the status of a not-for-profit Association under the Swiss law. Its secretariat is based in Geneva (Switzerland).

PIC/S aims at harmonising inspection procedures worldwide by developing common standards in the field of Good Manufacturing Practice (GMP) and by offering word-class training to regulatory inspectors. It also facilitates co-operation and networking between competent authorities, regional and international organisations. For more information, see www.picscheme.org

To lead the PIC/S Secretariat, the PIC/S Executive Bureau, has been mandated to recruit a new EXECUTIVE DIRECTOR

Main responsibilities

The statutory position of the Executive Director is that of “PIC/S Secretary”. He/she reports directly to the PIC/S Chairperson, whom he/she is assisting in his/her mandate. The full job description is available at the following link: https://picscheme.org/en/publications

In summary, the Executive Director is responsible for the overall delivery of secretariat services to the PIC/S Committee and other PIC/S bodies, which report to the Committee. The Executive Director contributes to (i) the elaboration of PIC/S overall strategies and policies and (ii) the general co-ordination, planning and supervision of PIC/S activities. He/she provides policy analysis and leadership in developing and implementing, amongst others, innovative management approaches, communication strategies, project management, and work programmes. He/she is also responsible for PIC/S finances and the preparation and implementation of the PIC/S budget.

The Executive Director acts as Secretary to the PIC/S Executive Bureau (EB), of which he/she a non-elected Member, with no voting right. He/she works closely with the EB to ensure the smooth running of activities and the successful development and expansion of PIC/S. He/she represents PIC/S externally upon request of the EB.

The Executive Director is the head of the PIC/S Secretariat, in charge of directing and managing the Secretariat’s human, financial and other resources (e.g. IT) in line with the relevant rules and procedures (in particular Staff Agreement and Financial Rules).

Profile

• Advanced university degree is required. Additional diploma are a plus.
• Professional experience in working for a national or international organisation for at least 10 years (of which at least 5 at managerial level).
• Experience with human and financial resource management, complex projects management, negotiations, and international policy processes.
• Fluency in written and spoken English with good communication skills. Knowledge of other languages, in particular French, is a further asset.
• Swiss, EU/EEA or UK citizenship

For the full list of requirements, see job description.

Start of contract / employment

January 2025

Job location

Geneva, Switzerland

Employment conditions

Full-time employment (100%)

Gross annual salary of CHF 185,000 (excl. bonus & benefits, see below)

Attractive working conditions (6 weeks holidays, flexible working hours, remote working, contribution to health insurance, child allowance, bonus, etc.)

Application process

Please send a motivation letter and CV to Marina.Ditesheim@picscheme.org by 31 July 2024 by mentioning “Application to PIC/S Secretary” in the subject line”.

You will be notified of the receipt of your application by the outsourced recruitment agent. Short listed applicants will be contacted regarding the next steps of the selection process.

As an equal opportunity employer, PIC/S welcomes applications from all suitably qualified candidates, irrespective of sex, gender, sexual orientation, marital or parental status, ethnic or social origin, disability, religion, or belief.

Zimbabwe applies for PIC/S pre-accession

Geneva, 6 June 2024:

On 20 October 2023, the Medicines Control Authority of Zimbabwe (MCAZ) applied for PIC/S pre-accession. The pre-accession application was considered complete on 6 December 2023. The Rapporteur is in the process of being appointed by written procedure.

JAPAN / PMDA collaboration with PIC/S and WHO

Geneva, 10 April 2024:

At its meetings of May and November 2023, the PIC/S Committee welcomed the announcement made by Japan / PMDA that it would second one PMDA expert to the PIC/S Secretariat in Geneva (Switzerland).

Since 1 April 2024, Dr SUZUKI Hirofumi, PMDA, has been seconded to the PIC/S Secretariat where he is going to serve in order to facilitate PIC/S Secretariat activities including collaboration with the World Health Organization (WHO) with a view to strengthen regulatory capacity building in the Asian region (for more information, see link)

Dr SUZUKI will support the PIC/S Secretariat regarding the harmonisation of GMP standards and the training of inspectors for PIC/S Participating Authorities, especially in Asia. Dr SUZUKI has several years of experience in various PIC/S bodies as well as in participating in PIC/S on-site assessment visits. He will help supporting the operation of PIC/S activities with a focus on Asia.

PMDA has been a Member of PIC/S since 2014. This secondment represents an innovative way by PMDA to support PIC/S and it will help strengthen the PIC/S Secretariat in line with PIC/S’ Strategic Plan (2023-27).

6th PIC/S Expert Circle Meeting on Good Distribution Practice (GDP)

Geneva, 30 January 2024:

The Department of Health and the Pharmacy and Poisons Board of Hong Kong (PPBHK) hosted the 6th PIC/S Expert Circle Meeting on Good Distribution Practice (GDP) from 29 November to 1 December 2023 via Zoom. A total of 230 participants joined the meeting. The meeting included discussions on contemporary issues and latest developments in the field of GDP and supply chain integrity; consolidating lessons learnt during COVID to support uninterrupted supply chain of medicine; sharing experiences between inspectors to improve consistency among inspectors in the field of GDP; and exchanging ideas and fostering collaboration among inspectorates. Follow us on LinkedIn.