1. Contamination Control Strategy Throughout Medicinal Products Life-cycle
Mr. Kriangkrai KAEWCHAIYAPHUM (Thai FDA)
Q1.
If the foreign manufacturer wants to register a new drug(NCE) in Thailand, could GMP on-site or paper-based inspection be waived with MFDS GMP certificate? (Both countries are PIC/S members.)
A1.
If a foreign manufacturer wants to register a new drug(NCE) in Thailand with MFDS GMP Certificate, only the GMP Clearance process is required with paper-based assessment only. No duplicate on-site inspection needed.
There are 2 conditions that would consider with MFDS GMP Certificate;
1. MFDS inspected a manufacturer within their territory (Domestic inspection) is considered as PIC/S pathway.
2. MFDS inspected a manufacturer outside their territory (Overseas inspection) is considered as Certified by PIC/S pathway.
A company who wants to register a new drug(NCE) in Thailand should consult this GMP Clearance process & registration process with an authorized importer/sponsor in Thailand as this is one of duties of the registered pharmacist in charge of their company
2. Contamination Control Strategy Following the Diversification and Expansion of the Global Pharmaceutical Supply Chain - The Malaysia Experience
Ms. Kim Mi HNG (Malaysia NPRA)
Q1.
If the foreign manufacturer wants to register a new drug(NCE) in Malaysia, could GMP on-site or paper-based inspection be waived with MFDS GMP certificate? (Both countries are PIC/S members.)
A1.
Generally, a foreign manufacturer that has a valid GMP Certificate issued by Korea MFDS (PIC/S Participating Authority) may be accepted for products to be registered in Malaysia. However, NPRA Malaysia will reserve the right to inspect the foreign manufacturer, should there be a need.
3. Establishing a CCS: A Regulator's Perspectives
Prof. Chong Hock SIA (Singapore HSA)
Q1.
If the foreign manufacturer wants to register a new drug(NCE) in Singapore, could GMP on-site or paper-based inspection be waived with MFDS GMP certificate? (based on MRA between the countries)
A1.
When the Korea-Singapore MRA on Pharmaceutical GMP Inspection is officially implemented, there will generally be no duplication of GMP inspections in each other’s jurisdiction.
A GMP Certificate or equivalent that is granted by Korea MFDS can be submitted as part of product registration of a new drug containing a new chemical entity (NCE). The GMP Certificate or equivalent document may be submitted to Singapore HSA under the “Documentary Evidence Verification Approval (DEVA) route.
+82-10-8307-4303
2024akgmp@gmail.com
+82-10-8307-4303
2024akgmp@gmail.com
1. Contamination Control Strategy Throughout Medicinal Products Life-cycle
Mr. Kriangkrai KAEWCHAIYAPHUM (Thai FDA)
Q1.
If the foreign manufacturer wants to register a new drug(NCE) in Thailand, could GMP on-site or paper-based inspection be waived with MFDS GMP certificate? (Both countries are PIC/S members.)
A1.
If a foreign manufacturer wants to register a new drug(NCE) in Thailand with MFDS GMP Certificate, only the GMP Clearance process is required with paper-based assessment only. No duplicate on-site inspection needed.
There are 2 conditions that would consider with MFDS GMP Certificate;
1. MFDS inspected a manufacturer within their territory (Domestic inspection) is considered as PIC/S pathway.
2. MFDS inspected a manufacturer outside their territory (Overseas inspection) is considered as Certified by PIC/S pathway.
A company who wants to register a new drug(NCE) in Thailand should consult this GMP Clearance process & registration process with an authorized importer/sponsor in Thailand as this is one of duties of the registered pharmacist in charge of their company
2. Contamination Control Strategy Following the Diversification and Expansion of the Global Pharmaceutical Supply Chain - The Malaysia Experience
Ms. Kim Mi HNG (Malaysia NPRA)
Q1.
If the foreign manufacturer wants to register a new drug(NCE) in Malaysia, could GMP on-site or paper-based inspection be waived with MFDS GMP certificate? (Both countries are PIC/S members.)
A1.
Generally, a foreign manufacturer that has a valid GMP Certificate issued by Korea MFDS (PIC/S Participating Authority) may be accepted for products to be registered in Malaysia. However, NPRA Malaysia will reserve the right to inspect the foreign manufacturer, should there be a need.
3. Establishing a CCS: A Regulator's Perspectives
Prof. Chong Hock SIA (Singapore HSA)
Q1.
If the foreign manufacturer wants to register a new drug(NCE) in Singapore, could GMP on-site or paper-based inspection be waived with MFDS GMP certificate? (based on MRA between the countries)
A1.
When the Korea-Singapore MRA on Pharmaceutical GMP Inspection is officially implemented, there will generally be no duplication of GMP inspections in each other’s jurisdiction.
A GMP Certificate or equivalent that is granted by Korea MFDS can be submitted as part of product registration of a new drug containing a new chemical entity (NCE). The GMP Certificate or equivalent document may be submitted to Singapore HSA under the “Documentary Evidence Verification Approval (DEVA) route.