As PIC/S expansion continues, what does this mean for manufacturers in those countries seeking to join?

Over the last few years the expansion of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has continued at pace, with more Good Manufacturing Practice (GMP) Inspectorates joining, bringing the total at the start of 2020 to 53 Participating Authorities.

Many of these regulators have needed to adapt their GMP standards to PIC/S standards as part of this process, often requiring manufacturers in their territories to make changes to comply with the new standards or face regulators sanctions, including potentially being forced to shut down.

PIC/S growth

There are currently 3 applicants undergoing assessment to become a PIC/S Participating Authority and 5 pre-applicants, where the pre-accession process helps the pre-applicant understand the gaps between PIC/S requirements and its GMP Regulatory Compliance Program. This can then support development of a gap analysis to resolve any concerns prior to making a full application to PIC/S to become a Participating Authority. (1)

The 3 applicants are:

· Armenia (SCDMTE)

· Brazil (ANVISA) – on site evaluation conducted October 2019

· Bulgaria (BDA) – on site evaluation planned Q1 2020

The 5 pre-applicants are:

· Bangladesh (DGDA)

· Jordan (JFDA)

· Pakistan (DRAP)

· Russian Federation (Minpromtorg, Russia FSI “SID&GP”, and Roszdravnadzor)

· Saudi Arabia (SFDA)

An example of where evolution of standards is required to join PIC/S can be seen by the adoption of PIC/S GMP into law in Brazil through Resolution RDC 301, which “Provides for the General Guidelines for Good Drug Manufacturing Practices”. This change clearly demonstrates a transition to the PIC/S internationally recognized standard as part of the application process, as RDC 301 is a direct translation of PIC/S GMP. This process has been replicated across many members who have joined previously and those that are currently in the process of doing so. (2)

Depending on the scale of this change and the size of the gap, this can have an impact on manufacturers if they are not operating at widely accepted international norms. Some Regulators that have joined PIC/S previously have taken regulatory action against companies that did not perform to the new required standards.

In a global pharmaceutical supply context, this is important with a country such as Brazil which has a large pharmaceutical manufacturing base. This becomes increasingly more significant as PIC/S membership grows further, and may potentially see applications from dominant global supply counties, such as China and India. PIC/S held a bilateral meeting with China (NMPA) on a possible future PIC/S application or pre-application at the last Executive Bureau meeting held in Toyama, Japan in November 2019. (1)

Evolving standards

PIC/S Participating Authorities co-operate and engage in the field of GMP along with its Partner Organizations:

· The European Medicines Agency (EMA)

· The European Directorate for the Quality of Medicines (EDQM)

· United Nations Children's Fund (UNICEF)

· World Health Organization (WHO)

· World Organisation for Animal Health (OIE)

Working together to develop PIC/S GMP guidelines, there is currently a lot of change occurring, in particular with the revision of Annex 1 (manufacture of sterile medicinal products) and Annex 2 (manufacture of biological medicinal substances and products for human use). Additionally, increasing efforts are being put into wider implementation of risk based methodologies and inspection reliance programs.

How can Parexel help companies and Regulators that need to adapt?

Parexel’s Regulatory & Access consulting organization includes former regulators from global agencies including the U.S. FDA, U.K.’s MHRA and NMPA in China and is exceptionally well placed to help companies advance through regulatory and market access hurdles, as well as being able to support Regulators in developing risk based methodologies and approaches.

(1) https://www.picscheme.org/en/news

(2) Resolução da Diretoria Colegiada - RDC nº 301 de 21/08/2019

Note: The author represented MHRA at PIC/S from 2009-2019 and was Chair of the PIC/S Subcommittee on Training from 2016-2019.

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