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.

US-FDA Formal Meetings with OTC Sponsors

Overview: On February 1st, 2022, the US Food and Drug Administration (FDA) issued a draft of guidance on formal meetings between sponsors of over-the counter (OTC) monograph drugs and the agency.The guidance clarifies how sponsors can obtain advice on studies to support their submissions. It also addresses meeting types, meeting formats, content of meeting requests […]

US-FDA TRANSITION PLAN FOR MEDICAL DEVICE UNDER EUA IN USA

On December 31st, 2021, the US Food and Drug Administration (FDA) published the draft of new guidance that outlines the transition plan for devices granted and marketed in USA under EUA designation during the coronavirus pandemic.

The US FDA deems final Order for Sunscreens

On September 24, 2021, FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs.

Regulatory Overview: Registration of Toothpaste in China

On October 21, 2021, the Chinese health authority (NMPA) has published a new regulation related to the requirements of Local testing as part of medical devices registration in China: “Regulations on the Administration of Medical Device Registration and Self-inspection”