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.
The US-FDA Grants Citizen Petition on Acacia (Gum Arabic) as a Dietary Fiber
On December 17, 2021, The U.S. Food and Drug Administration (FDA) recently granted a citizen petition concerning the classification of acacia (Gum Arabic) as a dietary fiber.
THE US-FDA: VQIP Application Portal Now Open for FY 2023
On December 1, 2022, the U.S.FDA will Open the Voluntary Qualified Importer Program (VQIP) application portal for fiscal year (FY) 2023.
US-FDA Announces New Requirements to Facilitate Export of Food Under China New Registration – Decree 248
On December 6, 2021 the FDA announced that establishments currently exporting certain food products to China to voluntarily submit information. The FDA is implementing this request in response to new facility registration requirements from China.
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”
China eCTD Requirements: Coming into Effect December 2021
On September 29,2021, China Health Authority (NMPA) published the technical specifications of Electronic Common Technical Document (eCTD) for the initial New Drug Application (NDA) and Biologics License Applications (BLAs) that will come into effect by December 29, 2021.
China New Requirements for Local Testing of Foreign Class II and Class III Medical Device
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”
Registration of Imported Pet food in China
If an overseas pet feed manufacturer exports pet compound feed or pet additive premix feed to China, it shall entrust an overseas enterprise’s office in China or an agency in China to apply for registration with the agricultural administrative department of the State Council and obtain an import registration certificate in accordance with the law.
Regulatory Overview: Registration of Children’s Cosmetics in China
In China Children’s cosmetics refer to cosmetics that are suitable for children under 12 years old and have the functions of cleaning, moisturizing, body conditioning, sun protection and etc.
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
Brazil’s Anvisa is accepted into International API Inspection Program
Anvisa is accepted as a member of the international API Inspection Programs.
An Introduction to Registration of Food Supplements in China
In China, nutrient supplements are regulated as one category under the umbrella term health food.