News

January 1970

Russia applies for PIC/S membership

Geneva, 13 January 2021: On 22 December 2020, the Competent Authorities of the Russian Federation submitted a complete membership application to PIC/S.  The Russian Competent Authorities are:

  • Ministry of Industry and Trade of the Russian Federation (Minpromtorg Russia)
  • Federal Service for Surveillance in Healthcare (Roszdravnadzor), including Federal State Budgetary Institution “Information and Methodological Center for Expertise, Accounting and Analysis of Circulation of Medical Products” (FGBU “IMCEUAOSMP” of Roszdravnadzor)
  • Federal State Institution “State Institute of Drugs and Good Practices” (FSI “SID & GP”)
  • Federal State Budgetary Institution "Scientific Center for Examination of Medical Devices" of the Ministry of Health of the Russian Federation (FSBI ''SCEMD”)

The Rapporteur(s) will be appointed either by written procedure or at the next PIC/S Committee meeting.

January 2021

Jordan applies for PIC/S membership

Geneva, 26 January 2021: On 20 January 2020, Jordan Food & Drug Adminstration (JFDA) submitted a complete membership application to PIC/S. 

The Rapporteur(s) will be appointed either by written procedure or at the next PIC/S Committee meeting.

January 2021

Revision of PIC/S Aide Memoires (PI 009-4; 024-3; 028-2; 038-2)

Geneva, 19 January 2021: the following PIC/S guidance documents have been revised:

  • PI 009-4 Aide Memoire on Utilities
  • PI 024-3 Aide Memoires on Biotech
  • PI 028-2 Aide Memoire on Packaging
  • PI 038-2 Aide Memoire on Assessment of QRM Implementation

The revision process consisted in updating the cross-references to the PIC/S GMP Guide. No other changes were made. The revised Aide Memoires enter into force on 1 January 2021.

 To download the revised Aide-Memoires, please consult the page “Publications

November 2020

Brazil / ANVISA joins PIC/S

Geneva, 30 November 2020 :  The PIC/S Committee has invited Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) to join the PIC Scheme.

Brazil / ANVISA will become PIC/S’ 54th Participating Authority as from 1 January 2021. ANVISA submitted a complete membership application in October 2014. A paper assessment was carried out followed by an on-site assessment visit which took place in October 2019, after a reorganisation at ANVISA. The assessment report was finalised in the course of 2020. The Audit team recommended to the Committee to accept the PIC/S membership application of ANVISA. After endorsement by the PIC/S Sub-Committee on Compliance (SCC), the PIC/S Committee then unanimously decided by written procedure completed on 27 November 2020, on the participation of ANVISA in PIC/S.

This is the first time in PIC/S’ history that an assessment process is completed by written procedure rather than at a Committee meeting. This was due to the situation with Covid-19 which prevented a Committee meeting taking place in 2020. A special welcome will be given to ANVISA at the next PIC/S virtual Committee meeting in 2021.

October 2020

PIC/S Expert Circle on Quality Risk Management (QRM) webinar, hosted by Turkey / TMMDA, 24 September 2020

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).

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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 revision of the PIC/S Aide Memoire on inspecting the implementation of QRM (PI 038-1) including discussions on the revision work in progress and gathering feedback on what the revised Aide Memoire should address;
  • The QRM Curriculum and the QRM e-Module being developed for the PIC/S Inspectorates’ Academy (PIA) and how these might be used by Inspectorates;
  • The PIC/S Recommendation Paper on Evaluating and Demonstrating the Effectiveness of the Pharmaceutical Quality System (PQS) with respect to Risk-based Change Management (PI 054-1 (Draft 1)) currently being applied on a trial basis by PIC/S Participating Authorities. See also interview of the Chair of the Expert Circle on this topic in Press Release of December 2019;
  • ICH Q12 and its relevance for GMP Inspectors, in particular training under development by the PIC/S Working Group on ICH Q12 Training Materials, chaired by France / ANSM, and the value of PI 054-1 (Draft 1) in this perspective.

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.

October 2020

PIC/S Seminar 2020

Geneva, 6 October 2020: Registrations for the 2020 PIC/S Seminar on "Distant Assessment of GMP Compliance" which will be hosted virtually from 8-10 December 2020 are now open (for Medicines Regulatory Authorities only). Deadline for registration is 8 November 2020.

For more information,  please contact the PIC/S Secretariat.

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seminar 2020

 

2020 Seminar on “Distant Assessment of GMP Compliance"  

The Finnish Medicines Agency (FIMEA) is hosting on-line the 2020 PIC/S Seminar on “Distant Assessment of GMP Compliance" on 8-10 December 2020.

This Seminar on Distant Assessment of GMP Compliance places special emphasis on real-time interactive assessment using ITC (Information Technology and Communication) tools. Distant assessment in the context of the Seminar is an interchangeable term with remote or virtual inspections.

The Seminar programme contains presentations and discussions on the implementation of distant GMP assessment/inspection activities in different jurisdictions and on information security in virtual real-time communications. We also look to share the experiences of inspectors involved in off-site GMP assessment/inspections as well as those inspected.

The Seminar is open to the participation of inspectors from medicines regulatory authorities around the world.

For more information, please contact the PIC/S Secretariat.