From the Inbox: GLP in China - what’s accepted, what’s possible, what’s wise?

Inspiration often turns up in unusual places. This month it arrived as a message from an old colleague, and it sharpened a question I hear a lot: what can you realistically do when your CTA includes non-clinical data from China? The colleague wrote with a familiar dilemma: data on file, an assessor unwilling to rely on it, and the hope that an EU GLP inspection might unlock acceptance. Can you “request” one to save the day? Short answer: not directly. Longer answer below.

Why this matters

Sponsors are attracted to Chinese facilities for sound reasons: strong science, modern labs, competitive pricing. My experience: none of that helps if data aren’t accepted in the target market. The goal is to shorten the path to “yes,” protect timelines, and avoid repeating pivotal studies.

The regulatory landscape (facts in brief)

• OECD MAD: EU authorities rely on other authorities’ GLP monitoring where the Mutual Acceptance of Data system applies. China is not currently an OECD member or MAD adherent, so automatic reliance does not apply.

• Who decides to inspect? EU/EEA authorities may coordinate inspections and information-sharing, but inspections are authority decisions, not something the sponsor commissions.

• Receiving-authority checks: There is formal OECD guidance for how regulators review the GLP status of submitted studies. This frames what your assessor may ask for.

What I see in practice (clearly labelled as experience/opinion)

• On sponsor motives: Choosing China is usually pragmatic, not corner-cutting. Teams are balancing science, timelines, capacity and cost.

• On facility motives: Some Chinese facilities welcome the chance of an EU inspection triggered via a submission. That can raise their international profile. It doesn’t guarantee acceptance for the sponsor.

• On “requesting” inspections: In my experience, sponsors cannot simply ask an EU inspectorate to go and audit a non-MAD facility. The lever you do have is to make it easy for the assessor to commission what they need.

• On timing: Even when an authority considers inspection, it may not fit your CTA timeline. Have a plan B ready.

Practical options if you’re holding Chinese GLP data

1. Go through the assessor, not around them
   Ask the CTA assessor what would let them rely on the data: a study-specific audit, a targeted facility inspection, or repeat work. Phrase the question in their risk-benefit terms.

2. Offer a tight evidence pack up-front
   For each decision-critical study, prepare a “mini-reconstruction”:

   • Protocols & amendments, SOP index

   • Test item/vehicle characterisation chain

   • QA oversight statements & deviation/CAPA summaries

   • Systems map: which electronic systems touched the data and how they were controlled

   • Archiving & raw data access arrangements

   • Histopath peer review summary (if applicable)
     My experience: this shortens scoping and often improves the quality of regulatory questions.

3. Clarify scope early
   Is the authority considering a study audit or a broader facility inspection? The more pivotal the study to the CTA decision, the broader the scope tends to be. (Observation from case work.)

4. Line up a contingency
   Identify the smallest set of pivotal studies you could repeat quickly at an OECD-MAD GLP facility. You don’t need to press go, but know the fastest viable route.

5. Future-proof your sourcing strategy

   • If your programme targets EU/UK/JP/US, prioritise MAD-adherent monitoring for pivotal studies from the outset.

   • Where you do place work in China, consider splitting: exploratory work there; pivotal decision-making studies in a MAD-covered facility. (Opinion: often the cleanest risk-reward balance.)

Nuances worth noting

• China’s domestic GLP: China’s NMPA has strengthened its own GLP certification regime for local submissions. That doesn’t equal EU reliance under MAD, which is the sticking point for CTAs filed in Europe.

• Japan’s model: For context, Japan’s PMDA accepts GLP studies from MAD countries and conducts product-based inspections for non-MAD origins. It signals how a major authority handles non-MAD data. EU practice is not identical, but the direction of travel is similar: authority-led, risk-based scrutiny.

Action box: what to do in the next month

• Map your portfolio: Flag any in-flight or planned studies outside MAD coverage that are pivotal for EU/UK filings.

• Prep the evidence packs: Build the “mini-reconstruction” bundles now so you’re ready for regulator questions.

• Engage assessors early: If a CTA is live, ask what concrete evidence or oversight would change the decision. Capture it in writing.

• Design your forward sourcing rule: For pivotal endpoints, default to MAD-covered facilities unless there is a strong, documented reason not to.

Closing thought
If you could rewind six months, where would GLP oversight have made this easier: study placement, contracting, or documentation? Small upstream choices prevent very expensive downstream fixes.

Want a second pair of eyes on your study sourcing plan or an evidence-pack checklist? Book a short call and we’ll pressure-test it together.

References

1. OECD. Mutual Acceptance of Data (MAD) System. Paris: Organisation for Economic Co-operation and Development.

2. OECD. Good Laboratory Practice (GLP) and Compliance Monitoring. Paris: Organisation for Economic Co-operation and Development.

3. OECD. Series on Principles of GLP and Compliance Monitoring No. 1: OECD Principles of Good Laboratory Practice (as revised in 1997). Paris: Organisation for Economic Co-operation and Development.

4. OECD. Series on Principles of GLP and Compliance Monitoring No. 20: Guidance Document for Receiving Authorities on the Review of the GLP Status of Non-Clinical Safety Studies. ENV/JM/MONO(2019)25. Paris: Organisation for Economic Co-operation and Development; 2019.

5. OECD. National GLP Compliance Monitoring Programmes which participate in the Mutual Acceptance of Data (MAD) system: status and contact information. Paris: Organisation for Economic Co-operation and Development.

6. European Medicines Agency (EMA). Compilation of Union Procedures on Inspections and Exchange of Information (CoUP). Amsterdam: EMA; latest restructuring noted August 2024.

7. European Commission / EMA. Introduction to the Compilation of Union Procedures on Inspections and Exchange of Information. Amsterdam: EMA.

8. European Food Safety Authority (EFSA). Good Laboratory Practice (GLP): information for applicants and links to GLP monitoring authorities. Parma: EFSA.

9. Pharmaceuticals and Medical Devices Agency (PMDA), Japan. GLP Inspections conducted by PMDA. Tokyo: PMDA.

10. Oku Y, Saito H. Trends in good laboratory practice studies submitted for the marketing authorisation of pharmaceuticals in Japan (FY2017–FY2023). 2025.

11. National Medical Products Administration (NMPA), China. Administrative Measures for Drug GLP Certification (effective 1 July 2023). Beijing: NMPA.