Guidelines
EMA regulatory guidance update to prepare for Brexit
In preparation for the UK’s withdrawal from the European Union (EU), set to take place on 29 March 2019, the European Medicines Agency (EMA) and the European Commission have issued regulatory guidance to pharmaceutical companies. The EU wants to ensure that pharmaceutical companies plan for Brexit to avoid any impact on the continuous supply of medicines within the EU.
FDA updates its list of drugs without generics
The US Food and Drug Administration (FDA) announced in December 2017 that it had updated its list of drugs without generics.
FDA guidance aims to encourage abuse-deterrent generic opioids
The US Food and Drug Administration (FDA) has issued new guidance intended to encourage generics makers to make abuse-deterrent formulations of opioids.
Australian guidelines for biosimilars
Last update: 5 January 2018
The regulatory body for therapeutic goods in Australia is the Therapeutic Goods Administration (TGA).
Indian guidelines for ‘similar biologics’
Last update: 5 January 2018
The regulatory bodies responsible for approval of ‘similar biologics’ in India are the Department of Biotechnology (DBT) under the Ministry of Science and Technology through its Review Committee on Genetic Manipulation (RCGM), and the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare.
Stakeholders comment on FDA’s draft statistical biosimilarity guidance
The US Food and Drug Administration (FDA) released draft guidance on statistical approaches to evaluate similarity for biosimilars in September 2017 [1]. Comments from stakeholders on the guidance indicate that they want it to be more specific and narrower in scope.
FDA publishes new draft guidance for ADHD generic
In October 2017, the US Food and Drug Administration (FDA) issued new product-specific draft guidance for generic methylphenidate oral extended-release tablets.
India updates its similar biologics guidelines
The Indian Ministry of Health has revised its guidelines for approving ‘similar biologics’. The guideline was updated in order to make the regulatory pathway more robust and to align the guidelines further with global guidelines for biosimilars. The update was seen as essential in order to meet the ‘ever changing global standards’.
FDA releases 52 new and revised bioequivalence guidelines for generics
As part of its ongoing efforts to provide product-specific guidance for generics makers the US Food and Drug Administration (FDA) has again released several new and revised bioequivalence documents. The agency announced on 18 October 2017 that it had released 33 new draft guidance documents and 19 revisions to guidance documents on bioequivalence requirements for the development of generics containing 47 different active ingredients.
New guidelines expected to encourage generics in China
New guidelines have been finalized in China to try and make the country a more drug-friendly market, while also promising progress in the use of generics.
