GMP certification requirements in Argentina, Brazil and Mexico

Reports/ | Posted 17/09/2021 comments 0
138 AA011155

Marketing authorisation (MA) of a medicinal product is the process of reviewing and assessing the evidence to support that product, in relation to its marketing, finalized by granting of a licence...

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LATIN AMERICAN FORUM
Switching mAb Pfizer V18K30
Biosimilars and interchangeability in oncology
Posted 03/09/2021

Researchers from Brazil investigated, from a pharmaceutical perspective, a major proble...

Regulation-V13H16
Mexico introduces new decree on health regulation
Posted 27/08/2021

On 31 May 2021, COFEPRIS published the Decree which specifies changes to the Health Sup...

Application V15a16
Comparison of authorization requirements for biological and biosimilar medicines
Posted 27/08/2021

The development of biosimilar medicines presupposes a paradigm shift from the tradition...

Home/Non‐Biological Complex Drugs
Liposome V15L11

On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...

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Generics

Generic pharmaceutical policies in the MENA region
Generics/Research | Posted 17/09/2021
Sandoz launches ferumoxytol and pemetrexed generics
Generics/News | Posted 03/09/2021
Generics applications under review by EMA – July 2021
Generics/General | Posted 23/07/2021
The generics market in Brazil
Generics/Research | Posted 16/07/2021

Biosimilars

Bevacizumab biosimilars launched in Spain and Korea
Biosimilars/News | Posted 17/09/2021
Off-patent biologicals/Biomimics approved in Bolivia
Biosimilars/General | Posted 17/09/2021
Clinical development of biosimilars in the oncology setting
Biosimilars/Research | Posted 17/09/2021