Launch of a pilot good manufacturing practice single inspection program

Drug Establishment Licensing Bulletin 168, February 27, 2024

Launch of a pilot single inspection program: a global approach to good manufacturing practice (GMP) inspections of third country manufacturers.

On this page

• About the pilot
• Impact on Canadian drug establishment licence holders
• Contact us

About the pilot

Health Canada has begun piloting a GMP single inspection program with the Therapeutic Goods Administration and the Medicines & Healthcare products Regulatory Agency. These 3 regulatory authorities are all members of the:

• Access Consortium
• Pharmaceutical Inspection Co-operation Scheme
• International Coalition of Medicines Regulatory Authorities

This pilot aims to establish a coordinated global approach to GMP inspections of foreign manufacturing sites of common interest. Using our collective inspection resources, each authority has agreed to cover the scope of the other where possible. This reduces the need for multiple inspections of the same site.

This builds on the success of our existing collaborative GMP arrangements and will allow for:

• more efficient inspection reliance processes
• reduced regulatory burden on industry
• enhanced collaboration in our regulatory oversight of common global supply chains

Impact on Canadian drug establishment licence holders

We're currently identifying sites to inspect as a part of this pilot. We may contact you if we select one of the foreign buildings listed on your drug establishment licence (DEL).

There will be no changes to the process to:

• request a GMP inspection of a foreign building
• apply for or amend a DEL as stated in GUI-0002: Guidance on Drug Establishment Licence

Contact us

Contact us with questions about the pilot program.

Email: foreign.site-etranger@hc-sc.gc.ca

Related links

• Guidance on GMP Inspection Reliance (Pharmaceutical Inspection Co-operation Scheme) (PDF, 103 KB)
• Pharmaceutical Inspection Co-operation Scheme Strategic Plan 2023 to 2027 (PDF, 2.0 MB)
• Access Consortium statement on Good Manufacturing Practice inspections reliance and recognition evidence
• Access Consortium Good Manufacturing Practice (GMP) Statement (UK Medicines and Healthcare products Regulatory Agency)
• Access Consortium Good Manufacturing Practice (GMP) Statement (Australian Therapeutic Goods Administration)
• Therapeutic Goods Administration