Understanding Mutual Acceptance of Data
The OECD Mutual Acceptance of Data (MAD) system is one of the most significant regulatory agreements in the life sciences. Under MAD, non-clinical safety data generated in an OECD member or adherent country — using OECD Test Guidelines and GLP Principles — must be accepted by all other participating countries for regulatory assessment purposes. This eliminates the need for duplicative testing across jurisdictions, saving time, cost, and animal lives.
For Indian laboratories, MAD adherence means that GLP studies conducted in India can be submitted to regulatory authorities in the EU, US, Japan, Korea, and 30+ other OECD member states without requiring repeat studies. This represents an enormous commercial opportunity for Indian CROs and an equally significant data strategy advantage for sponsors placing studies in India.
India’s current MAD status
India has provisional adherence to the OECD MAD system for specific OECD Test Guidelines. This means that Indian GLP-compliant laboratories can generate data that is accepted internationally — but only for the test guidelines covered by India’s adherence, and only from laboratories that are GLP-compliant under NGCMA monitoring. The scope of India’s adherence has been expanding progressively, but it does not yet cover all OECD Test Guidelines.
What this means for Indian laboratories
For laboratories seeking to attract international study placements, NGCMA-certified GLP compliance is the essential prerequisite. Without it, MAD does not apply, and your data will not be accepted by international regulatory authorities. Beyond GLP certification, laboratories must ensure that their studies are conducted according to the specific OECD Test Guidelines covered by India’s MAD adherence. Studies conducted under alternative or modified protocols may not qualify.
Practical steps for international market access
Indian laboratories should: verify that their GLP certification covers the study types they wish to market internationally, confirm that their test methods align with the specific OECD Test Guidelines included in India’s MAD adherence, ensure that their quality systems meet international inspection standards (as international monitoring authorities may conduct follow-up inspections), and build commercial relationships with sponsors who value MAD-compliant data generation in India as a cost-effective alternative to studies in OECD member states.
LaborWissen provides guidance on GLP readiness for international market access, including OECD MAD compliance assessment, NGCMA inspection preparation, and commercial strategy for laboratories seeking international study placements.