Regulatory Affairs News

15 Mar 2016

Health Authority seeks to join PICS scheme

In February 2016, Mexico updated its regulations 059 and 164 regarding the Good Manufacturing Practices (GMP) of drugs and active pharmaceutical products with the goal of joining the Pharmaceutical Inspection Cooperation Scheme (PICS). The GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to […]

25 Feb 2016

ANVISA improves timeframes for medical device market applications

According to an analysis of data from the Brazilian Health Surveillance Agency (ANVISA) performed the Medical Device Consulting EMERGO, Brazilian regulators for the medical device market have reduced timeframes in 2015 for responding to and processing submissions from registrants of some medical device market applications. Throughout most of 2015, ANVISA was able to provide initial […]

Latin American health agencies agree regarding online drug salesLatin America
11 Feb 2016

Latin American health agencies agree regarding online drug sales

Health agencies of Mexico, Spain, Colombia, Paraguay and Central America, signed a letter of intent (LOI) aiming to strengthen joint surveillance on the sale of medicines over the Internet and reduce health risk. Health agencies agreed to create a regional observatory (Observatorio Regional) to monitor Internet medicine sales and to establish legal mechanisms to fight […]

28 Jan 2016

Drug registration hits new high

According to the recent statistics released by the Brazilian Health Surveillance Agency (ANVISA), 742 medicines were registered in Brazil in 2015, a 105 percent overall increase over 2014. Among these, there has been a 116 percent increase in the authorization of generics over 2014 and a 286 percent increase in similar drugs. Additionally, ANVISA has […]

List of pesticides available onlineBrazil
13 Jan 2016

List of pesticides available online

The Brazilian Health Surveillance Agency (ANVISA) announced that since December 21, 2015, pesticide registrations analyzed by its Toxicology General Department (GGTOX) will no longer being published in pdf or similar format, but instead are available through ANVISA´s Registration System (Datavisa) at: In Brazil, pesticide registration is evaluated by three Agencies: the Ministry of Agriculture […]

Pursuing WHO certification for medical devicesMexico
16 Nov 2015

Pursuing WHO certification for medical devices

During the first Medical Devices Congress “Eyesforpharma Latin America 2015,” the Federal Commissioner of the Mexican Health Authority (COFEPRIS) Mikel Arriola announced that in 2016 Mexico will seek the World Health Organization (WHO) certification for medical devices. COFEPRIS has already this certification for drugs and vaccines. The main objective of the WHO certification is to […]

08 Oct 2015

Health authority issues new regulation

Provision 7130/2015, concerning the active pharmaceutical ingredient “antimicrobial activity”  published in September in the Official Gazette, should be applied to the presentation of the sale of medicinal preparations registered or entered in the Register of Medical Specialties ( Registro de Especialidades Medicinales, REM). This new provision complies with Argentina´s strategy for the Control of Antimicrobial […]

new rules for food and medicine in ArgentinaArgentina
01 Oct 2015

New rules for food and medicines

The National Health Authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica – ANMAT) issued disposition 6516/2015 regarding advertising of food and medicines. According to Article 1, companies owning products subject to sanitary surveillance shall notify the health authority of any advertising, traditional or not, aimed at the general consumers, and file the corresponding advertising […]

Modernization policy deregulatesMexico
25 Sep 2015

Modernization policy deregulates more than 2,200 medical devices

A list of 2,242 deregulated low-health risk medical devices and products that are no longer considered to be health consumables has been generated since September 2, 2015. These devices will no longer require the submission of a health registration or import permit to Mexican customs. The two-step deregulation process started in 2012 with a first […]

Speed-up of approval time for clinic research protocolsMexico
08 Sep 2015

Speed-up of approval time for clinic research protocols

The Federal Commissioner of the Mexican Health Authority (COFEPRIS) Mikel Arriola has recently announced that Mexico has become the most competitive Latin American country regarding the approval times for clinic research protocols for new drugs, which have been reduced from three to one month. This time reduction has been possible due to the collaboration of […]

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