Food Supplements in Latin America : Market overview and Regulations
Latin America is becoming a land of opportunity for many emerging markets and Food Supplements are rapidly becoming more popular in the LATAM region.This blog will overview Brazil, Mexico and Argentina Market potential for food supplements and relevant regulation specific to each region.
China’s NMPA announces Delay of Unique Device Identification (UDI) Implementation
Due to the Coronavirus, Chinese Regulatory Authority, National Medical Products administration (NMPA). decided to delay UDI implantation to next year January 2021.
Brazil’s Anvisa updates requirements for Good Distribution and Storage Practices Certification (CBPDA) for Health Products
Anvisa changes the list of documents for Good Distribution and Storage Practices Certification petitions for health products.
Brazil’s Anvisa publishes guide about cyber security in medical devices
Anvisa publishes Guide 38/2020, “Principles and Practices of Cyber Security in Medical Devices”. The document is intended for anyone interested in ensuring the safe use of medical devices and will be useful for users of such equipment, patients, manufacturers, distributors, health services and researchers in the area of safety
Brazil’s Anvisa Announces New Medical Device Regulations
On September 18,2020 Brazil’s Anvisa published the RDC no. 423/2020 which deals with the extinction of the registration and migration of medical devices of risk class II to the notification regime.
China’s CDE publishes draft for a list of Drugs exempt from BE Studies
China’s CDE publishes draft listing 117 drugs that will be exempt from BE studies.
China’s NMPA Addresses Common Period Risk Evaluation Report (PRER) Issues
China’s NMPA updates and address some common issues faced by the Marketing Authorization Holders to submit PRER report.
China’s NMPA resolves issues regarding current administration on drug distribution
NMPA announces a new revised Drug Administration Law of the People’s Republic of China effective since Dec 1, 2019.
Mexico’s COFEPRIS establishes new electronic Appointment System
From September,1st 2020 COFEPRIS establishes the request for appointments will be via the internet and face-to-face attention in the CIS for the entry of priority formalities.
Mexico’s COFEPRIS promotes the production of generic drugs with new operating rules
COFEPRIS establishes operating rules to promote the production of generic drugs in Mexico, by eliminating criteria that limited their production and their availability at more accessible prices for the population.
Good Manufacturing Practices Certificate (CBPF) Renewal with Brazil’s Anvisa
Every Two years in Brazil, Manufactures must renew their GMP certificate known as CBPF, incorrect petition of this renewal will lead to rejection or return.
The UK’s MHRA provides more provisions on Pharmacovigilance
UK MHRA publishes UK, (12A) to Regulation 205A, providing provisions for pharmacovigilance activities and PMSF requirements.