On October 2022, the Japanese Ministry of Health, Labour and Welfare (MHLW) has published new quality standards and specifications of 2,647 ingredients and additives that can used in Quasi-drugs.
On July 2021, Regulators in Japan announced they will start conducting inspections by surprise at facilities where drugs, pharmaceuticals and medical devices products are manufactured
Overview: China’s National Medical Product Agency (NMPA) proposes a revision on pharmaceutical approval. The revision focuses mainly on generic drugs and how to increase the safety requirements for clinical trials, limit false clinical data and encourage drug approval process. China additionally released the second batch of urgently needed drugs from foreign manufacturers. New Drug Review […]
Japan’s MHLW issued on April 1, allowing institutional review board (IRB) meetings to be held online or via emails when urgent deliberations are needed to decide whether to approve clinical trials for COVID-19.
The FDA Prepares for the Fourteenth Annual Meeting International Cooperation on Cosmetics Regulation.
The FDA announces on March 3rd that they hold a public meeting regarding the 14th International Cooperation on Cosmetics Regulation (ICCR)- to be held on April 14, 2020.
The FDA, EMA and PMDA aim at bringing harmonization in regulations related to clinical studies conducted for novel antimicrobial drugs (antibacterial and antifungal) across USA, Europe and Japan.
[vc_row][vc_column][vc_column_text]On April 1st, 2018, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has raised the registration fees for most medical devices . PMDA fee increase is ranging from 8% to 15% across nine device categories as …
The Ministry of Health, Labor and Welfare is proposing a considerable cut down in the pricing of both off-patent drugs and expensive innovative treatments, and also set up an annual review of the drug prices.