MHLW says PIC/S membership means high quality drugs will get to patients faster

By Gareth Macdonald

- Last updated on GMT

MHLW highlights benefits of PIC/S at Tokyo tradeshow
MHLW highlights benefits of PIC/S at Tokyo tradeshow

Related tags Medicine

Japan’s membership of the PIC/S international inspection and manufacturing scheme bodes well for patients in Japan and elsewhere according to the Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency (MHLW)

The MHLW applied for Pharmaceutical Inspection Cooperation Scheme (PIC/S) membership in 2012 a year after the US Food and Drug Administration (FDA) joined the manufacturing standards organisation.

The Japanese regulator – and sister organisation the Pharmaceuticals and Medical Devices Agency (PDMA) – were accepted in July last year – in a decision that should facilitate greater international collaboration according to MHLW director, Haruo Akagawa.

Akagawa told delegates at CPhI Japan last week that “The purpose of PIC/S is to pursue and strengthen the cooperation established, to provide the framework for the sharing of information and experience on a voluntary basis.

I profoundly hope that [drug] candidates and innovative products will be delivered to patients as soon as possible, not only from Japan but also for the whole world with assured international quality levels and they will help patients suffering from diseases​” he said.


Membership of the PIC/S provides a basic set of good manufacturing practices (GMP) guides for active pharmaceutical (API) production and guides for the manufacture of sterile medicinal products.

The organisation also provides member organisations with seminars and training sessions relative to APIs, computerized systems, human blood tissues, quality risk management and good distribution practices.

PIC/S is also used by regulators to keep track of drugmakers’ compliance with manufacturing standards. Earlier this month​ the Taiwanese Food and |Drug Administration (FDA) used PIC/S data to conduct an assessment of drugs using magnesium carbonate after a sourcing scare.

In addition, European Regulators said greater participation in PIC/S was a key part of its 2020 strategy, explaining that increased information sharing was an important part of efforts to improve global standards.

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