In this week’s news, EMA says clinical trial database is working, UK wants to be part of EMA post Brexit, US FDA updates OTC drug guidance and more…
EMA says clinical trial database is a success
The EMA says its clinical trial database has been a success with drug companies sharing information in the correct format and with few redactions.
The Amsterdam-bound regulator made the comment last week to coincide with the publication of its clinical data transparency report.
Under the EMA’s transparency policy, citizens, researchers and academics, can access a database of clinical reports submitted by drug companies as part of marketing authorisation applications.
According to the report, 3,641 users have downloaded 80,537 documents ‘for non-commercial purposes’ since the database was launched in October 2016.
The EMA said,” There has been full compliance with the policy in the first year. The amount of CCI redactions in the documents published was very low, in only 0.01% of total pages published.”
The agency also said a user survey indicates people who have accessed the database understand the importance of making clinical trial data publically available.
“Very few respondents disagree with EMA’s rationale for developing the policy. In addition, most respondents strongly agree that publishing clinical data increases public trust in EMA’s decision-making and that it allows the reassessment of clinical data.”
US FDA outlines new ways of ensuring safe use of OTC drugs
The US Food and Drug Administration (FDA) has issued draft guidance designed to ensure non-prescription over-the-counter (OTC) medicines are used safely.
The document covers approaches that can be used “in cases where the drug facts labelling (DFL) alone is not sufficient to ensure that the drug product can be used 19 safely and effectively” according to the agency.
The methods suggested include the production of information leaflets, the development of supporting websites and the creation of mobile apps that can address users’ questions.
To ensure safe use, the FDA advocates that, prior to buying the products people, could be asked a series of questions either by the pharmacist or through the app.
Industry group welcomes vote making EMA membership a post Brexit goal
The ABPI has welcomed a vote in the UK Parliament that makes seeking continued participation in how the EU regulates drugs a priority for Government ministers in Brexit talks.
Last week Parliament approved amendment NC17 (see page 13) to the Trade Bill, which states that “it shall be the objective of an appropriate authority to take all necessary steps to implement an international trade agreement, which enables the UK to fully participate after exit day in the European medicines regulatory network partnership between the European Union, European Economic Area and the European Medicines Agency.”
The decision was backed by industry with ABPI CEO Steve Bates describing it as a “clear message that patients and public health should be a top priority for the Government in these negotiations.”
He pointed out that, “Every month, 37 million packs of medicine arrive in the UK from the EU and 45 million move the other way. Therefore, it is essential that the UK continues to participate in the EMA after Brexit.”
In related news, the BBC’s Newsnight program put together a video report on how the drug industry is preparing for Brexit.
EC updates Brexit planning advice for EU member states
The European Commission has reminded member states that drugs made in the UK will need to undergo the same procedures as those manufacturered in other third countries after Brexit.
The Commission made the comments in an updated version of its Brexit preparedness guide.
The organisation wrote that, “EU pharmaceutical law requires the marketing authorisation holder for a medicine to be established in the EU. Moreover, medicines manufactured in a third country undergo specific controls upon importation.”
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