Japan’s MHLW Publishes New Quality Standards for Quasi-Drugs
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.
Brazil’s Anvisa authorizes Remdesivir for Pediatric- Use in the treatment of Covid-19
Anvisa approved, on Monday (11/21), the extension of use of the antiviral drug Remdesivir for pediatric use in the treatment of Covid-19.
Brazil’s ANVISA Approves new Normative for the Registration of New and Innovative Medicines
On October 2022 Anvisa publishes approval measures for the registration of new and innovative medicines in Brazil
Brazil’s ANVISA Announces Medical Device Registration 2022 Updates
ANVISA Brazil announced in early September 2022 important updates to its Collegiate Directorate Resolution (RDC) 185/2001.
The changes strengthen the country’s medical device registration regulations on the effective date of March 1, 2023.
REGISTRATION OF DRUG MASTER FILE (DMF) IN JAPAN
In Japan, the Drug Master File (DMF) is called “Master File” or “MF”. The Purpose of DMF is to protect the “know-how” of API manufacturing methods against the marketing authorization applicant (MAA) / holder (MAH) of pharmaceutical products. The foreign manufacturers of APIs can apply for DMF registration.
Japan’s PMDA implements Surprise GMP inspections at manufacturing facilities
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
Japan’s PMDA Remote Inspections
The PMDA clarifies its requirements for conducting remote compliance inspections related to drugs and regenerative medical products.
Japan’s MHLW Allows Online IRB Meetings for Coronavirus Trials
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.
PMDA Approach to Artificial Intelligence (AI) based Medical Devices
PMDA has adapted emerging technologies such as AI based medical devices and has reviewed the registration process to make it more efficient.
HOW TO FILE A DMF FOR AN API IN JAPAN
GRP- blog explains the PMDA’s DFM application process and lists the necessary content needed for API submission to the PMDA.