• Regulatory NewsRegulatory News

    New COFEPRIS Guidance on Technovigilance Report Submissions

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Mexico’s medical device market regulator COFEPRIS has issued new guidance on its  technovigilance reporting program  (link in Spanish) for medical device manufacturers commercialized in the country. First  announced  in early 2013, the technovigilance system will support post-market device monitoring and management of adverse even...
  • US Blood Donation Process to Become Easier for Recent Travelers to Cancun, Cozumel

    Malaria-a mosquito-borne disease common in some developing countries that kills hundreds of thousands of people each year-is a serious threat to the health of even healthy humans. But as a new guidance document released on 19 August 2013 by the US Food and Drug Administration (FDA) notes, the disease isn't just confined to the developing world. There is a risk, albeit a small one, of malaria being transmitted during blood transfusions-a risk FDA believes is no longer refl...
  • Mexico Amends API Manufacturing Regulations to Meet EU Requirements

    • 01 July 2013
    Mexico's Ministry of Health, through the Federal Commission for Protection against Health Risks (COFEPRIS), has updated the country's requirements on Good Manufacturing Practices (GMPs) for active pharmaceutical ingredients (APIs) comparable to those issued by the European Union. The new GMP requirements come into force immediately and are mandatory for all establishments engaged in the manufacture and distribution of APIs. With this standard, Mexico believes that i...
  • Mexico, Turkey Petition to Join International Pharmaceutical Regulatory Group

    • 14 May 2013
    The Pharmaceutical Inspection Convention and Cooperation Scheme (PIC/S), an international forum for the exchange of regulatory information about pharmaceutical products, may soon see itself with two more members, it announced on 14 May 2013. Background The organization is made up of two distinct parts which are different with regard to their authority. The first part, the Pharmaceutical Inspection Convention, is a legally binding set of standards agreed upon and mutuall...
  • Feature ArticlesFeature Articles

    Biotechnological Product Roadblocks in Mexico

    • 08 April 2013
    On 1 July 2012 the Mexican people elected a new government. On 3 December the minister of health was replaced by Mercedes Juan López. The result of this change in leadership has yet to be understood. However, it is reasonable to assume that it may have legislative and operational implications for pharmaceutical companies with interests in Mexico. Recent announcements from the Ministry of Health have indicated a drive toward more timely approval of generic and innov...
  • US, Mexico Announce Plan to Strengthen Regulatory Cooperation

    US Health and Human Services Secretary Kathleen Sebelius and Mexico's Secretary of Health Salomón Chertorivski jointly announced the launch of a new program aimed at increasing regulatory cooperation at a meeting in Geneva, Switzerland on 22 May. Sebelius and Chertorivski were at the 65 th World Health Assembly, where both acknowledged their mutual goals in promoting public health. "It is important to strengthen the programs of regulation and surveillance of med...
  • US, Mexico and Canada Move to Harmonize Regulations

    US President Barack Obama, Canadian Prime Minister Stephen Harper and Mexican President Felipe Calderón announced at a press conference that the three contiguous countries are working together to harmonize regulatory approaches to facilitate cross-border trade. Speaking at the 2 April 2012 press conference, Obama announced the three nations were "launching a new effort to get rid of outdated regulations that stifle job creation."  "Here in the United States...