Kazakhstan moves closer to PIC/S: assessment mission set for 2027

The PIC/S Committee meeting hall in Istanbul
Photo: Kazakhstan Ministry of Health

Astana, 5 November, . A meeting in Istanbul on 2–3 November officially approved an on-site assessment mission and inspection in Kazakhstan for 2027, an important stage on the way to joining the international pharmaceutical inspection system PIC/S, the Ministry of Health said.

Inspectors of the National Centre for Expertise of Medicines and Medical Devices took part in the meeting. The Ministry of Health submitted its application in March 2025; in November that year the PIC/S Committee in Hong Kong confirmed the application was complete and appointed a rapporteur and a co-rapporteur. Inspectors were prepared for the assessment: they were trained in good manufacturing practice (GMP) and good distribution practice (GDP), a joint training audit with the World Health Organization was held, and internal procedures and regulations were updated, including on unscheduled inspections. The on-site mission will be the next stage: experts will review how the Kazakh inspectorate works in practice and carry out an inspection under observation.

The ministry links accession with international trust in the control of medicine production and with wider exports. Exports of pharmaceutical products grew by 17.8% in 2025, production of medicines rose by 37% to 191 billion tenge; in the first eight months of 2026 output reached 157.4 billion tenge, almost 30% more than a year earlier. Over two years investment in the industry grew 3.3 times and exports 1.9 times.

What it means: The decisive check is still ahead: the assessment mission will take place only in 2027, and the ministry did not name a date for joining PIC/S.

Who benefits: In the ministry’s assessment, Kazakh manufacturers, who could reach foreign markets, and patients, because quality control would be strengthened. The inspectorate would get more opportunities to exchange experience and train specialists.

Background: PIC/S stands for the Pharmaceutical Inspection Co-operation Scheme: an international system in which regulators of different countries agree on rules for inspecting medicine manufacturers and train inspectors. GMP (Good Manufacturing Practice) is a set of requirements for producing medicines, and GDP (Good Distribution Practice) for storing and transporting them. A GMP certificate confirms that a plant works to these requirements; the ministry notes that in a number of countries the PIC/S membership of the body that issued the certificate is taken into account when recognising a production site’s compliance.

We have also reported on medicine prices: the Ministry of Health says prices fell on 799 medicines and 494 more will be produced in Kazakhstan.