CARPHA CRS Recommends its First Biosimilar Product to help with Cancer Management

The CARPHA Caribbean Regulatory System (CRS) recently recommended its first biosimilar product which can become part of the support to cancer management in its Member States.  Pegfilgrastim, the active ingredient, is designed to boost the body’s immune response, thereby allowing cancer patients to keep fighting infections while receiving cancer treatments, such as chemotherapy, that harm blood cell production.  It may be used in the management of various cancers.

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ANMAT: Observer Member of the ICH

The Argentine National Administration of Medicines, Foods and Medical Technology (ANMAT) joins as an observer member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), in the framework of the Council´s meeting held at the beginning of June in Amsterdam, the Netherlands.

For 29 years the ICH has brought together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration to achieve greater harmonization worldwide to ensure that safe, effective and high-quality medicines are developed and registered in the most resource-efficient manner.

According to ANMAT, achieving the role of observer of ICH is an important distinction, since it is the preliminary stage to be part of the Council as a «regulatory member», allowing to consolidate its position as one of the world National Agencies of Reference.

For more information go to ANMAT webpage:



Central American Medicines Regulatory Authorities met to sign the “Joint Medicines Verification Mechanism” convention, which encourages the introduction of new drug therapeutic alternatives and thus benefit more than 40 millions of Central Americans. As witnesses of honor participated the representative of the Pan American Health Organization in Costa Rica (PAHO), Dr. María Dolores Pérez and the Vice-President of the Republic, Epsy Campbell Barr.


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Paraguay: New medicines supply chain management model has born, which will mark a milestone in Public Health area

With the support of several countries in the Americas and PAHO/WHO, Paraguay creates its model for universal and sustainable access to medicines and other health technologies, as well as their rational use, which will therefore benefit all public health services users.

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New WHO ‘School of INN’ to strengthen International Nonproprietary Names for medicines and promote a level playing field

 WHO launches the School of INN (International Non-proprietary Names). INNs are global names for medicines. They provide one reference generic name for each individual medicine that comes to market. Since 1953, the World Health Organization has named over 10 000 medicines.

The School of INN is an online platform where students of pharmacy and medicine, health professionals, scientists, drug regulators, industry, international organizations and civil society can follow short course modules and learn more about the science of drug nomenclature and what INNs do in practice.

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PAHO – Regulation of Advanced Therapy Medicinal Products: concept note and recommendations

It was published the document “Regulation of Advanced Therapy Medicinal Products: concept note and recommendations”, Ninth Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH) (San Salvador, 24 to 26 October, 2018).

The aim of this document is to highlight the progress made with regard to advanced therapy products, the risks associated with such products, and the regulatory challenges they pose for Member States with a view to strengthening regulatory systems. The document is also a call to action for governments to consider the development of standards and rules for regulating these products in order to control the use of unapproved therapies and prevent risks to the population. As discussed, there are cross-cutting regulatory principles that should be implemented by any regulatory body that plans to undertake the regulation and oversight of advanced therapy products.

Its rationale follows on previous discussions at the 2016 PANDRH Conference, and fulfills a recommendation by the Conference that requested PAHO to develop a concept paper on the subject.

The Regulation of Advanced Therapy Medicinal Products: concept note and recommendations, is available in English and Spanish, from:

Spanish –

English –


PAHO – Regulatory reliance principles: concept note and recommendations.

It was published the document “Regulatory reliance principles: concept note and recommendations. Ninth Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH) (San Salvador, 24 to 26 October, 2018)”.

The aim of this document is to outline key examples and principles for the practice of regulatory reliance. Its rationale is multifold: (a) it follows on previous discussions at the 2016 Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH), and (b) it fulfills a recommendation by the Conference that requested PAHO to develop a concept paper on reliance for PANDRH stakeholders to consider for endorsement. This concept paper builds on a presentation that was made at the 2016 Conference and integrates global thinking on the subject, including a recent document by the World Health Organization (WHO). The overarching goal is to ensure that PANDRH stakeholders continue to build understanding around reliance in ways that can better inform scenarios for its use.

The concept note is available here


CDERLearn Training and Education

CDERLearn in the Center for Drug Evaluation and Research (CDER) offers a variety of learning opportunities for healthcare professionals, industry, consumers, and academia. The goal is to create a body of educational and information modules about human drug regulation and activities. CDERLearn is a way to share FDA expertise in specific subject areas to further instruct the public about the many ways CDER protects and promotes public health.

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Belize became the first country in the CARICOM block of countries to publish a list of registered medicines

Belize began registering medicines as a result of the Food and Drugs (Registration, Licensing and Inspection) Regulations passed in 2017,  and the products that are listed are new to the country. Previously imported medicines that were available in the market prior to the new regulations were grandfathered into the system while ensuring its safety, efficacy and quality. The publication of a list of registered medicines is a best practice in transparency and accountability of regulatory systems as recommended by PAHO/WHO. Among the many benefits, it helps to provide the public and other stakeholders with visibility over what is legally approved to be sold in the market. Other countries in the CARICOM block can look to Belize as an important leader in this area.

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40th Medicine Recommended to CARICOM Governments

CARPHA’s Caribbean Regulatory System (CRS) recently recommended its 40th medicine to CARICOM governments. “This is an important milestone for the CRS because it shows that manufacturers are increasingly using the system and it can work” said Dr. Virginia Asin, who oversees the program as the Director, Surveillance, Disease Prevention and Control at CARPHA. The updated list of recommended medicines is publicly available on CARPHA’s webpage. 

The CRS assists the small states of CARICOM with the resource- and time-intensive task of evaluating medicines for safety, quality, and efficacy. Its approach requires that all medicines reviewed are already approved by a PAHO-designated reference authority, the European Union, or WHO Prequalification program. Once confirmed as eligible, the medicines intended for the CARICOM markets are verified as the same. Internal data show that the medicines available in highly regulated markets are not necessarily the same products that are sold in CARICOM.

Because the CRS is voluntary, manufacturers determine the products that they submit, but medicines should be listed on the WHO Essential Medicine List or be of public health value to the region. An increasing percentage of the recommended medicines treat non-communicable diseases (about 25% currently), which make up a large disease burden in CARICOM countries. Other products that are important to public health are included, such as antibiotics and antiretrovirals. The CRS recently recommended an innovative cure and an essential medicine to treat Hepatitis C that is not currently registered anywhere in the region.

The process of review by the CRS typically takes about 6-8 weeks from receipt of documents to decision-making and recommendation to CARICOM governments. This has been found to be much faster than the current timelines in the region. This accelerated processing also enables faster access to essential quality medicines for patients.

The list of recommended products is growing by the month and can be found HERE