Mexico and Costa Rica sign cooperation agreement on drugs and vaccines

Posted on October 22, 2013 by Maria I. Guaia

On the 17th of October 2013, COFEPRIS issued a press release informing on a new agreement of cooperation between the health authorities of Mexico and Costa Rica that will allow the recognition of drug registrations approved by COFEPRIS, by Costa Rica.

Federal Commissioner Mikel Arriola, head of COFEPRIS, remarked that the subscription to this agreement is possible today thanks to the international certification of the Mexican Health Agency as National Regulatory Agency of Regional Reference, awarded last year by the Pan American Health Authorization (PAHO).

This is one of the first steps towards harmonization of drug and vaccine registration in the region, which will promote commerce and enhance collaboration.

This agreement will also allow professionals of COFEPRIS to help the General Direction of Health, HA of Costa Rica, towards the achievement of the PAHO certification. This recognition is awarded after a thorough evaluation of the agencies’ performance of basic functions for ensuring the quality, safety and efficacy of medicines in the country. The assessment is based on recommendations of the World Health Organization (WHO) for strengthening the regulatory bodies.

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Argentina: checklist for GMP inspections of API facilities

Posted on October 22, 2013 by Maria I. Guaia

On the 3rd of September 2013, ANMAT (regulatory agency in Argentina) issued a new Disposition establishing the guidelines and checklists that will be used by its inspectors for GMP inspections of sites of manufacturing, elaboration, fractionating, distribution, commercialization, exports and imports of Active Pharmaceutical Ingredients (APIs).

This new checklists are based in ICH guidelines and include several items of the following aspects: Administration and General Information, Human Resources, Building Structure and Installments, Services Systems, Computarized Systems, Documents and Registers, Material Management, Production and in-Process Controls, Conditioning and Labeling of APIs and Intermediate Products, Storage and Distribution, Quality Control, Validations, Change Management, Rejection and Reutilization of Materials, Complaints and Market Recalls, Contract Manufacturers and QC Labs, Agents, Intermediates, Marketers, Distributors, Repackagers, APIs obtained by Cell Culture of Fermentation Methods, APIs for use in Clinical Trials and Quality Assurance.

The Disposition also includes the potential measures to be applied in case of deficiencies, from programed corrective measures to close-down of the facilities, indicating which deficiencies will bring what outcomes.

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Mexico: new guidelines for the acceptance of GMP certificates

Posted on October 18, 2013 by Maria I. Guaia

In October 2013, the Mexican health authority released a new document setting the criteria that will be used to accept GMP certificates as valid. This criteria applies to certificates of manufacturing facilities both of finished products and API.

Summary of the guidelines:

1- The following guidelines apply for new drug applications, variations and renewals of certificate of small-molecules (allopathic) products.

2- At the time of submitting the application dossier, the solicitor must have a GMP certificate of the finished product or API issued by:

  • COFEPRIS (Mexican health authority)
  • One of the health authorities recognized by COFEPRIS: FDA (USA), ANVISA (Brazil), Health Canada (Canada), EMA (EU), Pharmaceutical and Safety Bureau (Japan) and TGA (Australia) or,
  • Health authority of origin

The GMP certificate must be presented in original or notary-certified copy, be written in Spanish or have attached the Spanish translation by an authorized translator (perito traductor autorizado). It must be apostilled or legalized. If the validity period is not specified in the certificate, it will be considered of 30 months.

3- If the solicitor presents a GMP certificate issued by the health authority of origin, and this health authority is not any of those recognized by COFEPRIS, an analysis with focus on risk assessment will be performed to assess the compliance with GMP standards. This analysis will consider the record of the manufacturing site, its pharmacovigilance reports, other GMP certificates issued by COFEPRIS or other health authorities, sanitary alerts, and any other information that the authority might consider relevant.

4- If, as a result of the above-mentioned analysis, it is decided that there is not enough information of reason to consider the foreign GMP certificate proposed by the solicitor as valid, it will be necessary for the COFEPRIS to visit and inspect the manufacturing site to verify the compliance with GMP guidelines. This inspection will have to be requested by the solicitor via the established administrative processes, and the receipt for the application for inspection has to be evidenced to the Commission of Sanitary Authorization.

5- COFEPRIS will publish the list of GMP certificates that have been accepted by it, which can be considered as a reference for the above-mentioned analysis. The solicitors will then be able to request to COFEPRIS a note (constancia) stating that a certain GMP certificate has been recognized as acceptable, which will be attached to the submission dossier.

If you want a copy of the original guidelines (in Spanish) just send me an email: inesitag@hotmail.com

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New domain!

Posted on October 17, 2013 by Maria I. Guaia

Starting right now, we have a brand-new nice domain for our regulatory affairs information site and blog: LatAmPharmaRA.com

So exciting! Come by anytime!

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ANMAT launches online platform to report drug adverse reactions

Posted on July 13, 2013 by Maria I. Guaia

On July 10th, 2013, ANMAT implemented a system for electronic submission of reports on adverse reactions to drug products.  The system consists on an online form accessible from the website of the National System of Pharmacovigilance. You can access the online form here.

Healthcare professionals, the regulated sector (pharmaceutical companies, etc.) and patients can use this new system to notify adverse reactions.

This tool has been developed considering ICH standards. (E2B-ICH guideline on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports) Its purpose is to minimize mistakes, make the data submission more complete and efficient, improve the quality, precision and consistency of reports and establish a common methodology for the presentation of clinical information.

Reports can still be submitted using the previous methodology of downloading the form from the ANMAT website and sending it to the Department of Pharmacovigilance via email, (snfvg@anmat.gov.ar)  fax (0054-11-4340-0866) or regular mail (Av. de Mayo 869, piso 11º -CP AAD1084- Buenos Aires, Argentina) once completed.

The online reporting system is not yet available for notifications of ESAVI (Adverse Reactions Supposedly Caused by Vaccination and Immunization).

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Labeling update Argentina: gluten-free/gluten-containing compulsory claim

Posted on July 5, 2013 by Maria I. Guaia

Last month, after active lobbying by the Argentinian Association of Assistance to Celiacs, (ACELA) ANMAT decided to incorporate in the labeling texts of all drug products, information about their content of gluten.

Celiac disease is a condition that damages the lining of the small intestine and prevents it from absorbing parts of food that are important for staying healthy. The damage is due to a reaction to eating gluten, which is found in wheat, barley, rye, and possibly oats.

This new regulation, Disposición 2574/2013 defines ‘gluten-free’ products as those composed only by ingredients that, naturally or after purification, are free of protein from wheat, from all Triticum species, oats, barley and rye, and from their crossed species.

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Gluten-free drug products, under all marketing conditions (OTC, Rx, etc.) must now include in their information leaflets and packaging labeling the claim: ‘Este medicamento es libre d e gluten‘ (‘This drug product is gluten-free’) and the gluten-free symbol which is already being used for labeling of food products. (image on the left) Both the claim and the symbol have to be easy to identify and read.

Marketing authorization holders must submit the analysis that verify the gluten-free condition and GMP certificates, to assure that the drug products are not contaminated with gluten. The analysis have to be performed on raw materials, intermediate and finished products, and the raw materials suppliers must submit an analysis protocol corresponding to the respective specifications.

All oral-dosage form drug products registered in ANMAT must comply with this new regulation within a year from the date of enforcement. (2nd May, 2013)

On the other hand, all registered oral-dosage form drug products that cannot prescind of gluten in their formula, have to justify its presence and quantify gluten per dosing unit. Within a year from the date of enforcement of this regulation, all theses drug products must include the following warning: ‘Este medicamento contiene gluten‘. (‘This drug product contains gluten’)

An antecedent to this resolution is an ICH specification (passed on to the USP, the European and the Japanese Pharmacopoeias) for wheat starch, restricting the content of total protein to o.3% in pharmaceutical products, thus reducing the level of gluten in this excipient.

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