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?
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.
Brazil’s Anvisa releases a new Adverse Event Notification Form
Brazil’s Anvisa introduces new tool enables faster and easier notification of drugs and vaccines.
HSA releases New Initiatives for Registration of Therapeutic Products- Aug 2021
As part of HSA’s ongoing efforts to enhance clarity in regulatory requirements and processes, and make regulatory information easily accessible to encourage good submission practices by the industry, the HSA has introduced an online self-guided tool for post-approval minor variations application and a DMF acknowledgment email and guidance on deficiency matters.