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FDA’s global inspection strategy strengthened

The US Food and Drug Administration (FDA) has implemented a modernized approach to ensure the safety and quality of globally produced innovator and generic medicines. Through its Program Alignment, FDA’s Office of Regulatory Affairs has modernized its workforce and approach to improving public health to keep up with globalization and increasingly complex supply chains. Since FDA implemented Program Alignment in 2017, the regulation of generic medicines has become increasingly strategic, risk-based and efficient.

China issues list of generics needed in the country

Authorities in China have introduced an initiative which the country hopes will boost the development of generics by encouraging pharmaceutical companies to develop and produce them.

Generics applications under review by EMA – July 2019

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].

Gilead’s Truvada will face generics competition in 2020

Gilead Sciences’ HIV blockbuster Truvada will face generics competition in the US in 2020, a year earlier than expected.

Pharmacy benefit managers use spread pricing to increase profits in Michigan

A report released in April 2019 raises new questions about the role of Pharmacy Benefit Managers (PBMs) in Michigan, specifically their use of spread pricing to increase profits at the expense of pharmacists, taxpayers and patients.

Multi-state lawsuit alleges widespread generic price fixing in the US

A sweeping lawsuit filed on 10 May 2019 by over 40 US states alleges that a number of major drug companies conspired to inflate the prices of generic drugs by as much as 1,000%.

US Court rejects Teva’s lawsuit over generic Restasis

The US District Court for the District of Columbia has discarded lawsuits from generics giant Teva Pharmaceutical Industries (Teva) regarding its first-to-file exclusivity rights on a generic version of the blockbuster dry eye drug Restasis (cyclosporine).

FDA releases statement on generic drug quality

A statement released by the US Food and Drug Administration (FDA) responds to recent press reports of quality issues and outlines the Agency’s ongoing efforts to maintain the quality of generic drugs manufactured both in the US and overseas.

Spotlight on the role of pharmacy benefit managers in the fight against rising drug prices

High prices of prescriptions have become a major issue for patients and politicians in the US. In addition to scrutiny of pharmaceutical companies, the role of distributors, insurance companies and middlemen including pharmacy benefit managers (PBMs) is now attracting attention. 

Pilot procurement scheme in China cuts drug prices

The Chinese pharmaceutical market, which is dominated by domestic manufacturers, is the second largest in the world in terms of value after the US. In a bid to lower drug prices for patients and reduce costs for manufacturers, the Chinese State Medical Insurance Administration introduced a national pilot scheme for tendering with minimum procurement quantities in a recent round of reforms across 11 major cities. If proven successful, the scheme is expected to be rolled out across China.