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COLOMBIA | Regulatory | Colombian Regulatory Authority publishes Immunogenicity Evaluation Guide for Biopharmaceuticals
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On 27 September 2016 -and by means of Resolution 4490/2016 (in Spanish)-, the Ministry of Health and Social Protection issued the Immunogenicity Evaluation Guide for Biological Medicines.
The Guide regulates Decree 1782/2014 -in Spanish- (which establishes requirements and procedures for pharmacological and pharmaceutical evaluations of biological medicines in marketing authorization process) with regard to the guidelines to be met by manufacturers, applicants and titleholders of marketing authorizations to ensure the safety of biopharmaceuticals.
The Guide will enter into force one year after its issuance date, and implies that the criteria established in Decree 1782/2014 also starts to rule.
Immunogenicity determines how likely is a molecule to elicit an immune response in an organism. According to the Resolution, its evaluation is mandatory because (i) its results could be unpredictable, (ii) it can be generated by any biological medicine and (iii) could have clinical consequences on its effectiveness or safety.
The parameters of the Evaluation Guide can be found in the text of the Resolution.
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URUGUAY | Patents | Uruguay agrees to join the PCT in Free Trade Agreement signed with Chile
On 4 October 2016, the Presidents of Chile and Uruguay signed a Free Trade Agreement (FTA) between the two countries, which in its intellectual property section establishes that Uruguay must adhere or ratify the Patent Cooperation Treaty or PCT (1970).
In previous years Uruguay has indicated that will adhere to the PCT, but this time is committed by means of a Treaty (FTA) to adopt that Agreement, once the FTA is approved by the Congress of the subscribing countries and entries into force.
LATIN AMERICA | Trademarks | INTA will open a Latin America and Caribbean Representative Office
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The International Trademark Association (INTA) approved the creation of a Representative Office for Latin America and the Caribbean, according to the INTA’s objective of consolidate an international expansion, improving its presence in the region, increasing the participation of its members and strengthening its links with Trademark Offices and Associations of the region.
The office will be located in Santiago de Chile and will be inaugurated in 2017 First Half.
In the next link you will find more information about the new office.
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COLOMBIA | Regulatory | Colombian Ministry of Health extends the deadline to obtain certification of Good Laboratory Practices in the Quality Control of Pharmaceuticals
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By means of Resolution 4620 of 3 October 2016, the Ministry of Health and Social Protection gives a new deadline for laboratories that provides quality control services in pharmaceutical products to certify their good laboratory practices when developing these functions.
The new deadline to obtain the certification is 18 months from the date of issue of Resolution 4620 of 2016.
