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”
Brazil’s Anvisa approves two new cannabis-based products
The Resolution RDC No.327/2019 establishes requirements for the marketing of cannabis products for medicinal purposes. So far, there are seven cannabis products approved by ANVISA.
Brazil’s Anvisa approves new regulatory framework for low-risk drugs subject to notification
The Resolution RDC No. 576/2021 and the Normative Instruction No. 106/2021 expanded the list of drugs that may have simplified registration. The notification process aims to simplify the regularization of low-risk drugs.
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”
Brazil’s Anvisa expands the Authorization for Clinical Trials with Medicines in Brazil
Amendment of Resolution No. 9/2015, which provides for clinical trials with medicines in Brazil, allows, on an emergency and temporary basis, the use of analyses performed by foreign authorities that are members of the ICH.
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.
Brazil’s Anvisa authorizes melatonin in food supplements
The approval of Melatonin as an acceptable ingredient in food Supplements occurred through the amendment of Normative Instruction (IN) No. 28/2018,
THE US-FDA TO MODERNIZE CDER’S EXPORT CERTIFICATE PROGRAM
On December 3, 2021, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) will begin issuing electronic Certificates of Pharmaceutical Product (eCPPs) and will no longer issue or mail paper CPPs.
Brazil Regulatry Breakdown: Food supplement or specific medicine?
The food supplement category was created in Brazil in 2018 to ensure the population’s access to safe and quality products. However, there is still confusion about the framing and registering the products in brazil ; is it a Food Supplement or is its a specific medicine?