Compliance

One of the essential requirements to join PIC/S is that Competent Authorities must have the arrangements necessary to apply an inspection system comparable to that referred to in this Scheme and whose requirements and procedures could ensure the proper implementation of the Scheme and contribute to its effective operation. Being equivalent is not only required for accession but all the time and duly verified during reassessments. This is why compliance to the PIC Scheme is one of PIC/S’ most important and critical areas, which needs to be constantly monitored.

PIC/S Sub-Committee on Compliance (SCC)

Compliance to the Scheme has been entrusted since 2014 to a specific Sub-Committee on Compliance (SCC), chaired by Ms Anne Hayes (Ireland / HPRA).

Assessment and Pre-Assessment

It usually takes between 3 and 6 years before PIC/S Membership is achieved through the PIC/S' Accession process, which can be preceded by a pre-accession process (for more details see "Accession"). During the assessment period, various changes and improvements recommended by the PIC/S Committee may have to be implemented; if necessary, follow-up assessment visits are undertaken by a PIC/S delegation to verify the suitability of corrective actions. 

Re-Assessment

For many years, only Applicants were subject to assessment. Founding Members were, however, never assessed. In order to ensure that both new applicants and older members fulfil the same requirements, a Joint Reassessment Programme (JRP) was launched in 2000 under which existing PIC/S Members (Participating Authorities) are now also reassessed for equivalence on a regular basis.

Results of other assessments such as those under the EU Heads of Agencies’ Joint Audit Programme (JAP), the (pre-) MRA inspections, etc. can be accepted. The assessment results under the JAP are accepted on a mutual basis in order to avoid unnecessary duplications. Of course, the principle of mutual acceptance only applies between programmes using equivalent sets of tools (e.g. PIC/S JRP and EU JAP).

There is only one PIC/S tool for the assessment and reassessment of PIC/S Members (Audit Checklist). Auditors used under the PIC/S assessment / reassessment should be trained according to the JRP-JAP training module (for more details see "Training for Auditors").

For the complete mandate of the SCC, see box below.

The mandate of the SCC is to

  1. Co-ordinate, plan and monitor all assessments, pre-assessments, re-assessments, etc.
  2. Co-operate with the Secretariat on the validation (i.e. completeness) of (pre)applications
  3. Plan and review (i) the assessment of Applicants and Pre-Applicants; and (ii) the re-assessment of Participating Authorities (PA)
  4. Review and assess communications from Inspectorates, which could trigger a reassessment
  5. Pre-select Rapporteur / Team Leader and Auditors who are appointed by the CO
  6. Review reports and recommendations by Rapporteur / Team Leader
  7. Monitor and review corrective actions by Applicants and Re-Assessed PA and ensure that they are followed up and fully implemented
  8. Ensure consistency of assessments and re-assessments (and between them)
  9. Ensure that Accession, Pre-Accession & Re-Assessment Guidelines (including Questionnaire and Checklist) are implemented / adhered to and make proposals for their amendment
  10. Define and review the tools used for assessment and re-assessment of PA (e.g. the audit checklist) in close co-operation with interested parties such as the EMA Compliance Group and EU MRA Partners (in particular Health Canada)
  11. Co-operate with EU Joint Audit Programme, the European Heads of Medicines Agency network and other similar initiatives in order to avoid duplication of work
  12. Report back to the PIC/S Committee, as provided for in the Terms of References, and summarises discussions on on-going applications
  13. Make proposals / recommendations