Regulatory Affairs News

11 Aug 2015

ANVISA has reduced the average authorization time by 165 days

According to the latest survey conducted by the Brazilian Health Surveillance Agency (ANVISA), the average time for any petition related to permits is 45 days. In September 2012 it was 210 days, so this is a reduction of 165 days. The time reduction is the result of a series of actions taken by ANVISA over […]

05 Aug 2015

Cooperation on pharmaceuticals with France

On July 11, the Health Agencies of Mexico (COFEPRIS) and France (ANSM) signed a Collaboration Agreement on pharmaceuticals, vaccines as well as medical and cosmetic devices with the aim of exchanging regulatory information and experiences that facilitate access of patients to safe, efficient and high-quality products. According to the Federal Commissioner of COFEPRIS Mikel Arrióla, […]

16 Jul 2015

List of “clone” drug applications now available

The Brazilian Health Surveillance Agency (ANVISA) recently published a list of applications relating to the simplified procedure for the approval, post-approval and renewal of generic,similar, specific, dynamized (i.e. homeopathic) and phytotherapeutic(herbal) drugs, as well as biological products linked to the technical and clinical reports of a “mother” application (related to a “mother” or reference drug). […]

07 Jul 2015

Change for the registration of cosmetics

On June 2, 2015, the Brazilian Health Surveillance Agency (ANVISA) published Decision 202/2015 changing the way of registration for cosmetics, personal care products and perfumes.Since June 15, 2015, the registration of these products must be done exclusively through the Agency Registration System (Datavisa), instead of the previous Electronic Automatic System (SGAS). For cosmetics, personal care […]

15 Jun 2015

Colombian and Spanish Health Authorities fight against counterfeit drugs

In May 2015, staff of the Colombian Institute of Food and Drugs Surveillance (INVIMA) and the Spanish Agency of Medicines and Medical Devices (AEMPS) attended a conference in Cartagena de Indias (Colombia) focused on the fight against counterfeit drugs. The event also aimed at the implementation of the FALFRA System, an online system for the […]

Mexico and the Caribbean
13 May 2015

Closer ties between Mexican and Caribbean Health Authorities

The Mexican government recently announced an increased cooperation regarding public health with 16 countries and eight territories in the Caribbean. The efforts will be focused on the consolidation of the regulatory capacity and technical training of the Caribbean institutions, and the access to Mexican generic drugs. With the aim of formalizing this collaboration, representatives of […]

28 Apr 2015

Mexican universities and research centers authorized as third parties to test biotech drugs

In an unprecedented move, the Mexican Health Authority (COFEPRIS) has authorized a university and two research centers as third parties to perform the characterization tests and preclinical studies needed to demonstrate the biosimilarity of biotech drugs submitted to COFEPRIS. In order to formalize this alliance, COFEPRIS has signed cooperation agreements with the National Autonomous University […]

08 Apr 2015

Cooperation between Health Authorities of Mexico and UK

With the aim of improving public health and facilitating the import/export of drugs and medical devices, Health Authorities of Mexico (COFEPRIS) and the United Kingdom (MHRA) recently signed a Cooperation Agreement. The “Exchange of Information Agreement,” which was signed during the official visit of the Mexican President Enrique Peña Nieto to London, is derived from […]

25 Mar 2015

New regulations for clinical trials in Brazil

Aimed at speeding up the start of clinical trials for the development of new drugs and health products, Regulations RDC 09/2015 and 10/2015 were published on March 3, 2015, in the Official Gazette. The new regulations, which revoke the previous RDC 39/08, take on a regulatory model in line with the main international health agencies […]

17 Mar 2015

Chilean Health Authority participates in APEC event about Drug Security and Counterfeit Drugs

Staff members of the Department of Inspections of the Chilean National Drug Agency (ANAMED) attended “Building Inclusive Economies, Building a Better World” hosted by the Asia Pacific Economic Cooperation (APEC) recently in Philippines. The program was focused on Drug Security, Good Storage and Distribution Practices and Counterfeit Drugs. This program is held yearly as part […]

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