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
An Introduction to Registration of Food Supplements in China
In China, nutrient supplements are regulated as one category under the umbrella term health food.
NMPA publishes new guideline for faster approval of Medical Device
China’s State Council publishes a new Medical Device Regulation (Order no. 739) to follow conditional approvals on rare diseases treating medical devices
NMPA releases a final guidance on Device Master File (DMF) submissions
As per the Announcement no. 36 of 2021, lists requirements for voluntary submission of domestic Class III and imported Class II and III medical devices and IVDs.
New Rules for Cosmetics Registration in China starting May 2021
The new regulations on cosmetics in china are coming into effect on May 1st, 2021. They include new classification of cosmetic product, new requirements for the ingredients, labeling, safety assessment and animal testing.
How China’s NMPA Monitors Adverse Events due to Vaccines Handling
On February 10, 2021, The CDE (Center for Drug Evaluation) of the NMPA in China has recently released “Guidelines for Acceptance and Review of Chemical Drug Changes”GRP Blog outlines how the NMPA reviews the application after receiving it and any necessary notes when preparing the application.
How China’s NMPA Review Application for Chemical Drug Changes
On February 10, 2021, The CDE (Center for Drug Evaluation) of the NMPA in China has recently released “Guidelines for Acceptance and Review of Chemical Drug Changes”GRP Blog outlines how the NMPA reviews the application after receiving it and any necessary notes when preparing the application.
China’s CDE releases Guidelines for Acceptance and Review of Chemical Drug Changes
On February 10, 2021, The CDE (Center for Drug Evaluation) of the NMPA in China has recently released “Guidelines for Acceptance and Review of Chemical Drug Changes” with Information on requirements for completing a Chemical Drug Change.
Rare Diseases in China: Approval and Coverage of Orphan Drugs
In December of 2020, the National Security Health Administration has also updated its annual list of drugs that are covered under the Basic Medical Insurance Plan.
Cosmetic Registration and Filing Management of new Cosmetic Materials in China Part II
On January 12,2021 China’s Health Authority, the NMPA released The Regulation “Measures of Cosmetics Registration and Filing Management” and will come into effect May 1, 2021.