Turkey's PIC/S membership: is a Turkish GMP certificate accepted abroad?
TİTCK has been a PIC/S member since 1 January 2018. What this gives a Turkish GMP certificate, where it falls short, with EAEU and Uzbekistan examples.
Short answer
The Turkish Medicines and Medical Devices Agency (TİTCK) became a full member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on 1 January 2018, as the 52nd participating authority. This means TİTCK's GMP inspection system was assessed and accepted against PIC/S standards. It does not mean that Turkish GMP certificates are automatically accepted in every country: PIC/S describes itself as a non-binding, informal co-operative arrangement, and it is not a trade agreement.
The accession process
TİTCK filed its formal application on 3 May 2013. In February 2017, PIC/S inspectors from Ireland, Switzerland, New Zealand, Argentina and Malaysia assessed TİTCK on site and observed GMP inspections carried out by Turkish inspectors at manufacturing sites. The decision was announced at a meeting in Taipei. Under its PIC/S membership, TİTCK also updated the format of GMP certificates for human medicinal product manufacturing sites (notice of 28.05.2018).
What PIC/S provides
PIC/S aims to develop harmonised GMP standards, harmonise inspection procedures, train inspectors and assess inspectorates; its website lists 57 participating authorities. Members can share GMP inspection reports on a voluntary basis and automatically join the Rapid Alert System for defective batches. According to PIC/S, membership may facilitate mutual recognition agreements (MRAs) and “may facilitate the export of pharmaceuticals”, and some non-PIC/S authorities accept GMP certificates from PIC/S participating authorities.
What it means for Turkish GMP
According to TİTCK's 2022 Reliance Guideline for GMP Assessments, the Turkish GMP guideline for human medicinal products is fully aligned with the PIC/S GMP Guide. The same guideline allows TİTCK, on another authority's written request, to share information such as a site's GMP compliance status, the GMP inspection report and the follow-up corrective and preventive actions on a voluntary basis; financial, commercial and trade-secret data are not shared. In the other direction, TİTCK can use documents from PIC/S member authorities under reliance when assessing sites of imported products; this does not mean adopting the other authority's decision, and TİTCK keeps its right to inspect.
Where it is not enough
The target market's own rule decides. In the Eurasian Economic Union (EAEU), third-country sites are inspected by a member state's inspectorate under EEC Council Decision No. 83 and receive an EAEU-format GMP certificate; the EEC has stated that GMP certificates from third countries are not recognised unconditionally. In Uzbekistan, Decree UP-137 requires a national GMP certificate for registration from 1 January 2026, and the simplified recognition route depends on the reference regulator being on the WHO WLA list or at GBT ML4, not on PIC/S membership.
Practical notes for exporters
Keep your TİTCK GMP certificate current, check the target country's GMP acceptance rule before planning shipments, and remember that the importing country's authority can request information from TİTCK. TİTCK has also been an ICH observer since November 2017 and a full ICH member since 27 May 2020. CSC follows these rules for exports of Turkish-origin medicines; to request a quote, please use the Medicine Request Form on our website.
Source: PIC/S, Members (accession: Turkey/TMMDA, January 2018), About and Benefits pages, picscheme.org; TİTCK, news item “TİTCK PIC/S Üyeliğine Kabul Edildi” and International Cooperation page, titck.gov.tr; TİTCK, Reliance Guideline for GMP Assessments (İyi İmalat Uygulamaları Değerlendirmeleri İçin Güven Kılavuzu), version 01, 2022; TİTCK notice on current GMP certificate formats, 28.05.2018; EEC Council Decision No. 83 of 3 November 2016; Decree of the President of Uzbekistan UP-137 of 19.08.2025 (lex.uz).