Generics/General
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.
CMS proposes new measures to rate generic usage
The Centers for Medicare & Medicaid Services (CMS) is actively working to promote competition and lower costs for drugs, according to a statement released in February 2020, which also details new measures of generics usage to help calculate a plan’s star rating.
Science, outreach, development: US Generics Drugs Office reaches new highs in 2019
The US Food and Drug Administration (FDA) Office of Generic Drugs 2019 Annual report gave updates on the number of generics approvals in 2019. These remained high at 1,014 [1-3]. The report also discussed the progress of the FDA’s Drug Competition Action Plan (DCAP) and FDA’s Generic Drug User Fee Amendments (GDUFA) programme [4], and information about the achievements of the Office of Generic Drugs (OGD) in terms of research proposals, outreach activities and international development.
Improving the pathway for generics approval in the US: 2019 update
The US Food and Drug Administration’s (FDA) Office of Generic Drugs released their 2019 annual report in February 2020. This gave updates on the number of generics approvals in 2019 which reached 1,014. It also gave information on the progress of FDA’s Drug Competition Action Plan (DCAP) and FDA’s Generic Drug User Fee Amendments (GDUFA) programme in 2019.
