Americas Health Authorities Meeting

On the 20th and 21st of February of 2014, representatives of the five Latin-American Health Authorities of Regional Reference recognized by the Pan American Health Organization, plus those of the FDA, Health Canada, and El Salvador’s regulatory agency met in Acapulco, Mexico, for a Summit of Health Authorities.

The topics of the agenda were regulation harmonization, reduction of transaction costs, and facilitation of access to drug products and vaccines of high quality and low cost.

Representatives of the American Health Authorities. Photo: COFEPRIS website.

Representatives of the American Health Authorities. Photo: COFEPRIS website.

The Health Authorities certified as of Regional Reference currently are those of Mexico (COFEPRIS), Argentina (ANMAT), Colombia (INVIMA), Brazil (ANVISA) and Cuba (CECMED). During the meeting, the representatives of FDA and Health Canada announced their decision to seek the PAHO certification for their own institutions.

The recognition will follow an evaluation of the agencies’ performance of basic functions, recommended by WHO, for ensuring the quality, safety and efficacy of medicines in their countries. For more information on the System for Evaluation of the National Regulatory Authorities for Medicines, please refer to the PAHO website.

The regulatory agencies agreed to work together on three main tenants in 2014:

  • Strengthening of the regulatory capacity of the group: exchange of site inspection and drug product reports to avoid duplicate work, acceleration of marketing authorization approval for drug products, and reduction of barriers for new molecules to enter the markets, with the aim of reducing costs.
  • Increase of technical cooperation to support other agencies in the region and invite other countries to be observers of the group.
  • Design and implementation of a communication strategy for all involved parties to stay current on the progress of the consolidation of the Health Authorities network.

The agreements were signed by Mikel Arriola (Mexico), Rafael Pérez Cristiá (Cuba), Carlos Alberto Chiale (Argentina), Ana Paula Soares (Brazil), Blanca Elvira Cajigas (Colombia), Howard Sklamberg (USA) and Cathy Parker (Canada).

The next meeting of the group will take place next September in Washington, DC. 

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Recommended movie: Fight to Live (2012)

The documentary FIGHT TO LIVE follows the pursuit of emerging cures for terminal diseases as told through the stories of patients, patient advocates and the companies who stake their future on the discovery of new treatments.

http://www.imdb.com/title/tt2084832/ It can be rented in iTunes for a low price.

Without taking a side in the debate, I recommend this film to all my regulatory affairs colleagues. It made me reflect about the delicate relation between health agencies and pharma companies wanting to assure superior efficacy and an acceptable safety profile, and patients needing urgent solutions to live or improve their quality of life.

It’s easy to lose the connection between what we do at the office every day and the patients at the other end. This week, let’s remember our patients and work for them.

Maria

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http://www.pharmaphorum.com/articles/what-is-the-current-situation-in-the-pharma-markets-of-latin-america-interview-with-market-access-expert

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Top 10 Pharma – products in the pipeline

Did you know that you can consult which new innovations are in the pipelines of the top 10 pharma companies directly from their websites?

Have a look!

1- Johnson&Johnson

2- Pfizer

3- Novartis

4- Sanofi

5- Merck&Co

6- GlaxoSmithKline

7- Abbott

8- Roche

9- Bayer

10- AstraZeneca

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Anvisa Approves Track and Trace System.

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List of FDA Advisory Committees

The FDA Advisory Committees for drugs and other healthcare products receive requests for technical and clinical evaluation of new drugs by the U.S. Food and Drug Administration. The committees, consisting of members from academic and clinical settings, the general public, and the pharmaceutical industry, make non-binding recommendations to the relevant divisions of the FDA about the advisability of approving new products.

Blood, Vaccines and other Biologics

  • Allergenic Products Advisory Committee
  • Blood Products Advisory Committee
  • Cellular, Tissue and Gene Therapies Advisory Committee
  • Transmissible Spongiform Encephalopathies Advisory Committee
  • Vaccines and Related Biological Products Advisory Committee

Drugs

  • Anesthetic and Analgesic Drug Products Advisory Committee
  • Anti-Infective Drugs Advisory Committee
  • Antiviral Drugs Advisory Committee
  • Arthritis Advisory Committee
  • Cardiovascular and Renal Drugs Advisory Committee
  • Dermatologic and Ophthalmic Drugs Advisory Committee
  • Drug Safety and Risk Management Advisory Committee
  • Endocrinologic and Metabolic Drugs Advisory Committee
  • Gastrointestinal Drugs Advisory Committee
  • Medical Imaging Drugs Advisory Committee
  • Nonprescription Drugs Advisory Committee
  • Oncologic Drugs Advisory Committee
  • Peripheral and Central Nervous System Drugs Advisory Committee
  • Pharmaceutical Science and Clinical Pharmacology Advisory Committee
  • Psychopharmacologic Drug Advisory Committee
  • Pulmonary-Allergy Drugs Advisory Committee
  • Reproductive Health Drugs Advisory Committee

Medical Devices

  • Device Good Manufacturing Practice Advisory Committee
  • Medical Devices Advisory Committee

Radiation-Emitting Products

  • National Mammography Quality Assurance Advisory Committee
  • Technical Electronic Product Radiation Safety Standards Advisory Committee

Other Advisory Committees and Boards

  • Risk Communication Advisory Committee
  • Science Board to the Food and Drug Administration
  • Science Advisory Board to the National Center for Toxicological Research
  • Veterinary Medicine Advisory Committee
  • Tobacco Products Scientific Advisory Committee
  • Food Advisory Committee
  • Pediatric Advisory Committee
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Brazil makes proposed outsourcing regulations available for comment.

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