Generics/General
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.
Generics approvals remain high in US in 2019
In February 2020, the US Food and Drug Administration’s (FDA) Office of Generic Drugs released their 2019 Annual report which highlighted the year’s key achievements. The report stated that in 2019, the Office of Generic Drugs (OGD) facilitated 1,014 generic drug final and tentative approvals. This is slightly lower than the 1,021 approvals of 2018 but remains high enough to make a positive contribution to the FDA’s generic drug programme.
US lawmakers question FDA on complex generics approvals
A US Congress Committee have sent a letter to the US Food and Drug Administration (FDA) regarding concerns over the approval of complex generics.
Russian drug shortages at ‘crisis point’
Russia has been facing limited access to foreign pharmaceutical products for several years, but recent reports suggest drug shortages are reaching ‘crisis point’.
Irish pharmaceutical association urges political parties to create a new medicines policy
The Irish Pharmaceutical Healthcare Association (IPHA) has urged political parties to mandate new policy to increase access to medicines ahead of the Irish general election, which was held on 8 February 2020.
Generics applications under review by EMA – January 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 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].
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].
FDA sets up centre to improve quality of compounded drugs
The US Food and Drug Administration (FDA) has established a Center of Excellence to improve the quality of compounded drugs, which are created by combining two or more drugs and are not FDA-approved.
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).
