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Ontario proposes regulatory changes to simplify drug formulary listing and cut government payments to pharmacies

Following a number of changes in Canada’s generics and biosimilars landscape in 2019 [1-3], the Ontario Ministry of Health and Long-Term Care (the Ministry) is proposing a number of changes to streamline drug formulary listing and reduce the payments it makes to pharmacies for dispensing drug benefits.

WHO prequalifies antiparasitic API

The World Health Organization (WHO) has announced the prequalification of Pyrimethamine, manufactured by Macleods Pharmaceuticals Ltd, as an active pharmaceutical ingredient (API).

FDA identifies causes of drug shortages, recommends solutions

In response to growing concern over drug shortages, the US Food and Drug Administration (FDA) has released a report and accompanying statement regarding causes and solutions for the problem.

UK Labour Party proposes state run generics manufacturer

In a speech at the 2019 Labour Party Conference, leader Jeremy Corbyn introduced the ‘Medicines For The Many’ initiative, which aims to put ‘public health before private profit’ and includes plans to establish a state-owned pharmaceutical company to manufacture generic medicines in the UK.

Ranitidine recalls escalate as FDA declares ‘unacceptable’ levels of NDMA in the drug

On 2 October 2019, the US Food and Drug Administration (FDA) declared that it had found ‘unacceptable’ levels of the probable human carcinogen N-nitrosodimethylamine (NDMA) in the heartburn drug Zantac (ranitidine) and its generic versions.

Carcinogen contamination halts distribution of generic Zantac

Heartburn drug Zantac (ranitidine) is being taken off markets worldwide following findings that the medications may be contaminated with cancer-causing agents.

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.

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