The news that the European Parliament has passed a law requiring all new EU clinical trials to be published in a publicly accessible database is a step forward for the transparency that is all-important for patients, the public, researchers and healthcare practitioners alike.
Two areas we focus on in our latest OTC.NewDirections bulletin are new regulations for dietary supplements and medical devices. In Canada, quality assurance measures are being introduced for Natural Health Products, while across the border in the US, the FDA has issued guidance to help marketers distinguish between liquid dietary supplements and beverages.
OTC.NewDirections, welcomes you to 2014 with the first bulletin of the year, where we are looking at the latest in clinical trial data transparency. The UK government has said it is “surprised and concerned” that data is routinely withheld from the medical and academic community. Meanwhile, a provisional agreement between the European Parliament and Council of Ministers would require both Pharmaceutical companies and academic researchers to upload all their results to a publicly accessible database. Continue reading
As the festive season fast approaches, several medicine agencies are reminding marketers of deadlines for certain marketing authorisation submissions. The European Medicines Agency has an imminent deadline for Type-IA variations (a change that has only a minimal effect, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned), while medicines agencies in Belgium, Denmark and Latvia have also issued reminders about upcoming deadlines. For more details, see tomorrow’s edition of OTC.NewDirections.
We’re looking at the European Medicines Agency’s (EMA) recently published report that identifies a number of action points on how to improve patient involvement in the evaluation of medicines, something that its stakeholders say is of “fundamental importance”. In other regulatory news, we’re catching up with what the FDA and the EMA are currently doing to combat medicines shortages as well as reporting on plans to investigate adolescents’ response to drug advertising, along with the rest of our regular regulatory updates.
In scientific news, we’re covering the latest research on e-cigarette effectiveness, which suggests that they help smokers quit and prevents them from going back to the habit. There’s also interesting news on how a low dose of aspirin taken daily by women trying to get pregnant appears to reduce the amount of time it takes them to conceive. Vitamin D, amino acids and magnesium are also under the spotlight, in addition to the latest in nutrition research.
For further detail on all these stories, don’t forget to check tomorrow’s edition of OTC.NewDirections.
Product safety is one of the key themes in our latest edition of OTC.NewDirections, with two stories related to supplements in Australia. The country’s medicines agency, TGA (Therapeutic Goods Administration), has announced a review of oxedrine (synephrine) and caffeine, both of which are ingredients commonly found in energy and weight loss supplements. The issue of caffeine’s safety has become a hot topic for regulators across the world, notably in the US, where the FDA has been reviewing 1,600 AERs (Adverse Event Reports) for caffeine-based foods and supplements.
Now two years since the FDA issued its draft guidance on the regulation of mobile medical apps, the agency has now published its long-awaited final guidance. Marketers will be relieved that the FDA has said it will only focus on the small proportion of apps that function like medical devices, such as those that turn smartphones into blood glucose monitors or electrocardiography machines, rather than all healthcare apps. Innovators in the field will appreciate the clarity that this guidance brings and the fact that the FDA will not require clinical trials for new apps that resemble medical devices already on the market.
In the latest edition of OTC.NewDirections, we reveal more on this story and provide a round-up of various other developments affecting medical devices over the past fortnight. These include new EU measures on medical devices in the wake of the breast implant scandal that broke in 2010, as well as an FDA ruling on unique device identification (UDI) systems and the agency’s effort to boost development of medical devices for children by awarding various grants.
Our latest edition also features expert commentary from our partners JensonR+ on a wide range of topics from restrictions on analgesics in Denmark, to homeopathy claims in the UK and classification changes for glucosamine in Finland. For more on these stories, and the latest scientific findings on supplements, make sure you subscribe to the bulletin.
In this week’s OTC.NewDirections Editor’s Comment, I will be looking at the latest developments in clinical trial regulations and how they are becoming more transparent in the nature. I will also be highlighting the changes for branded supplements and how they are beginning to show their benefits to the customer.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has expressed its concerns with the European Medicines Agency’s (EMA) draft policy on the publication and access to trial data, while in the UK, the Health Research Authority (HRA) is set to begin implementing plans to ensure trial information is publicly available.
In scientific developments, Sinetrol X-Pur (Fytexia) is showing that it could be a “viable option” for weight management and improving inflammatory, glycaemic and oxidative status. Branded ingredient Verisol (Gelita) has been found to significantly improve women’s skin elasticity and SesaVita (Olive Bioscience) may be beneficial in prediabetes management and mild-to-moderate hyperlipidemia. To find out why, read tomorrow’s bulletin.
For more information on these stories see our latest issue of OTC.NewDirections.