Thailand’s TFDA Hopes to Expedite GMP Certification of Foreign Drugs

Importers who purchase and bring into Thailand foreign drugs need to get those imported drugs registered in Thailand before they can be sold. One of the requirements for Thai drug registration is foreign drug facilities must meet GMP standards. Recently, the Thai FDA has announced a draft bill to expedite the GMP approval process. The draft bill will be reviewed by the Ministry of Public Health. Once enacted, this bill will offer a more reasonable program to global pharmaceutical policies for GMP inspections which should expedite drug approvals.

First, instead of submitting a GMP certificate or CPP, Thai drug importers sourcing from foreign drug factories who are in the Pharmaceutical Inspection Co-operation Scheme (PIC/S) or ASEAN listed Inspection Service, can provide other documents showing GMP conformity if they are applying for new approvals/renewals. The PIC/S program includes 56 regulatory authorities from around the world.  Second, for drugs coming from overseas factories not covered by point one above, Thailand will implement a new risk-based system focused on document requirements. Overseas drug factories with higher risk will now face more oversight, and have more document demands. Third, the Thai FDA will also be more open to reviewing other types of documents to assure GMP compliance instead of just relying on official CPPs and GMP certificates. In short, overseas drug factories that are regulated under PIC/S, will have less scrutiny and quicker GMP compliance, whereas other overseas factories would be evaluated more closely based on their overall risk.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.