Home / Generics / General

General

Generics applications under review by EMA – January 2021

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].

A European pharmaceutical strategy promoting generics and biosimilars

The European Commission has adopted a new Pharmaceutical Strategy for Europe [1], as of 25 November 2020.

Pfizer sues Aurobindo and Dr Reddy’s over Ibrance (palbociclib) generics

US-based pharmaceutical company, Pfizer, has filed petitions in US courts against Aurobindo Pharma and Dr Reddy’s Laboratories.

China prioritizes drug innovation while increasing access to drugs approved abroad

China's pharmaceutical industry is undergoing a transformation towards high-quality and innovation-focused development, which has led to an explosion of new drug and clinical trial approvals in recent years.

Brazil sees a COVID vaccine setback but treatment advancement

In Brazil’s quest to tackle the COVID-19 pandemic, there has been a volunteer death in a potential vaccine trial, but a potential treatment option has emerged. Brazil has the second number of COVID-19 deaths, with over 159,033 deaths recorded up to end of October 2020. 

Reforms to health policy needed in Europe

The President of Medicines for Europe has made four key recommendations for European Union (EU) pharmaceutical policy,  while the Irish Pharmacy Union (IPU) says reforms to the health service could save Ireland millions of euros.

Structural reforms are required to make Japan’s healthcare system sustainable

Japan’s healthcare system provides universal coverage and high-quality healthcare delivery. With relatively minor changes for nearly six decades, it has kept the country remarkably healthy. However, a recent study has highlighted that significant changes may be necessary to maintain long-term sustainability.  

The benefits of tracking generic drug quality

Resources such as the US Food and Drug Administration’s (FDA) Sentinel Initiative should be used to their full potential in order to monitor the quality of generic drugs, suggests a recently published research letter [1].

Generics applications under review by EMA – July 2020

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 27 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].

HIV drug Kaletra appears on Russian black market

There are several reports of a black market in Russia emerging for the HIV drug Kaletra, following claims that it can be used to treat COVID-19.