Regulatory Affairs News

medical devicesMexico
16 Aug 2016

Strengthening the local Medical device market

By Luisina Laura Lanza On April 28, 2016, the Joint Ordinary General Assembly for Medical Devices took place in Mexico D.F. organized by the Mexican Pharmaceutical Industry Chamber (CANIFARMA). At this meeting, the medical device market was strengthened between the countries of the Pacific Alliance (Colombia, Chile, Peru and Mexico). It should be emphasized that […]

medication ui pillsColombia
14 Jul 2016

Unique Drug Identifier required for new sanitary registrations

By Luisina Lanza The Directorate of Drugs and Biological Products of the Colombian Ministry of Health (MoH)– now requires the pharmaceutical drug industry to submit the corresponding Unique Drug Identifier (IUM, according to its Spanish acronym) for all pharmaceuticals for human use. The change is a result of Resolution No. 3166 in force since 2015, which defined and implemented […]

safety labelingU.S. and Latin America
05 Jul 2016

Opioid Analgesics: Safety labeling changes

By Luisina Laura Lanza The US Food and Drug Administration (FDA) is warning of several safety issues regarding opioid analgesics. These safety risks include potentially harmful interactions with many drugs, suprarenal glands problems and reduction in levels of sex hormones. The FDA is requiring changes to the label of all opioid medications in order to warn about these […]

Mexican Health Authority working with Germany and DenmarkMexico
11 May 2016

Mexican Health Authority working with Germany and Denmark

The Mexican Health Authority (COFEPRIS) has recently signed joint declarations with Germany and Denmark to promote and strengthen the cooperation and exchange of good practices regarding health risks. Regarding the agreement with the Danish Health Authority (DMA), the Federal Commissioner of COFEPRIS, Julio Sánchez y Tépoz, stated that “the agreement will allow the exchange of information in the field […]

clinical-protocols-to-be-assessed-in-2-monthsColombia
04 May 2016

Clinical protocols to be assessed in 2 months

On April 12, 2016, the Colombian National Institute for Drug and Food Surveillance (INVIMA) reported that the time to assess clinical trial research protocols will be reduced from 4.5 to 2 months. The reduction will be achieved through the improvement of the processes, without compromising the quality of the evaluation. Every clinical research project begins with the development of […]

mexico-and-korea-strengthen-bonds-of-cooperation-concerning-health-issuesMexico
26 Apr 2016

Mexico and Korea strengthen bonds of cooperation concerning health issues

The head of the Federal Commission for Protection against Health Risks (“Comisionado Federal para la Protección contra Riesgos Sanitarios”), Julio Sanchez y Tépoz, met with a delegation of Korean government representatives to help strengthen the communication and cooperation between both countries and improve the quality, technology, and effectiveness of healthcare consumables. “The relationship between South Korea and Mexico, regarding […]

new-post-approval-changes-of-drug-productsBrazil
22 Apr 2016

New post-approval changes of drug products

On March 22, 2016, the Brazilian Health Authority (ANVISA) approved the amendments of Regulation RDC 48/2009, which refers to the post-approval changes of drug products. The amendments establish a new regulatory framework for post-approval changes through the incorporation of different risk analysis depending on the complexity and the health risk of the modified drugs. Law 6.360 / 1976 establishes […]

health-authority-seeks-simplification-of-proceduresArgentina
19 Apr 2016

Health Authority seeks simplification of procedures

The Argentine Health Authority (ANMAT) has launched a public consultation aimed at simplifying the registration of almost 30 pharmaceutical active ingredients. The list includes both nonprescription, referred to as “over-the-counter” (OTC), and prescription medicines. The goal of the project is the unification of the technical assessment and the first batch authorization, so both requirements are performed in only […]

registration-of-food-products-now-online-onlyArgentina
04 Apr 2016

Registration of food products now online only

Beginning April 7, 2016, the registration of food products before the National Food Institute (INAL), a division of the National Administration of Drugs, Foods and Medical Devices (ANMAT), can only be made electronically through the Federal Information System for Food Control Management (SIFeGA). The previous hard copy registration system will no longer be available. Parties needing to request a health […]

Local Health authority signed a draft of cooperation agreement with El SalvadorBrazil
22 Mar 2016

Local Health authority signed a draft of cooperation agreement with El Salvador

The Brazilian National Health Surveillance Authority (Anvisa) signed a cooperation project with the Republic of El Salvador through the local regulatory agency for medicine, the National Directorate of Medicines (DNM – “Dirección Nacional de Medicamentos”) and the National Health Institute (INS – “Instituto Nacional de Salud”). The cooperation project will strengthen the technical capacity of […]

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