Last month, one of our news briefs discussed remote inspections for medical device GCP. Recently, the PMDA also issued remote GCP inspections for drugs and regenerative products. In August, the Japanese PMDA issued these guidelines in English. These guidelines advise on the... Read More
For medical device approvals in Japan, the Japanese PMDA must do a GCP compliance inspection of the clinical data with the applicant during a face-to-face meeting. This in-person inspection is normally done in a conference room at the PMDA. On August 24th, an... Read More
On June 1, 2022, Japan’s PMDA’s Medical Device Quality Control and Safety Measures Department issued an administrative communication called the “Documents to be submitted when applying for a QMS conformity inspection.” Administrative documents with the same QMS content have been published for some time, but this latest... Read More
Due to manufacturing problems with some generic products, the MHLW will now bolster GMP via issuing a new inspection manual. This inspection manual will apply to both generic and new drugs. Representatives from various pharmaceutical associations, the PMDA, and others have now set up... Read More
As drug registration applications grow dramatically in China, so will the CDE audits of drug manufacturing facilities according to the Center for Drug Evaluation (CDE). Earlier this year, the CDE set up a 3-tier system for audits of drug factories including low,... Read More
Last summer, the Japanese MHLW issued guidelines saying the PMDA and the prefectural authorities should do surprise GMP inspections on factories that have had many previous problems. The surprise GMP inspections were to stop factories from covering up sensitive issues before inspections.... Read More
The Malaysian National Pharmaceutical Regulatory Agency (NPRA) announced that it will implement a new good pharmacovigilance (GVP) inspection program at the beginning of 2023 with a voluntary phase. These inspections ensure that manufacturers of pharmaceutical products and their affiliates conform to the... Read More
In the latest move by India’s regulatory authority to better control the safety of medical devices, the Ministry of Health and Family Welfare announced in February that all retail and wholesale outlets selling medical devices in the country will be required to register with... Read More
Spurred by the harmonization of safety requirements on drug development by regulators in the United States and Europe, Japan’s drug regulators are tightening requirements on the development of new pharmaceuticals. By next year, for example, all products used in clinical trials must... Read More
The Japanese Ministry of Health, Labor and Welfare issued a notice on September 29, 2021 that stated that Japan has decided to formally start accepting MDSAP reports for medical devices and IVDs as part of the Japanese QMS process for product registration... Read More