A non-governmental organisation has published guidance that it says will give companies a "head-start" in meeting the challenges of complying with the provisions of the UK Bribery Act, which comes into force in April 2011 1-3 . Transparency ...
The European Medicines Agency has published its new policy on communicating safety-related issues relating to human medicines 1 ,2 . It follows growing consensus on the need to improve communication on benefit:risk process outcomes and to enhance ...
New legislation has been introduced in the US House of Representatives that would give mandatory product recall authority to the Food and Drug Administration 1 ,2 . The bill (HR 5740) was introduced by Edolphus Towns (Democrat ? New York), chairman ...
All drugs and medical devices purchased by the Indian government must now display GS1 barcodes on their packaging. The new requirement implemented by the Indian Ministry of Health and Family Welfare came into effect on 1 April 1,2 . The barcodes ...
The US Food and Drug Administration has finalised guidance on standards for securing the drug supply chain by using a standardised numerical identifier on prescription drug packs 1 ,2 . The guidance is the first in a series of several documents that ...
Maria Isabel Manley and Marina Barnden report on the worrying implications for the innovative pharmaceutical industry of the European Court of Justice ruling in ABPI v MHRA. It comes as a shock to the innovative pharmaceutical industry that, ...
Stefan Sandner and Annemarie Jasper argue that since OTC medicines contain well-established substances they should be regulated under a revised version of the Traditional Herbal Medicinal Products Directive and not under the more complex ...
Organisations representing independent prescribing publications, patients and healthcare advocates are urging members of the European Parliament's environment, public health and food safety (ENVI) committee to close the door to pharmaceutical ...
Vince Postill compares two anti-counterfeiting technologies and explains why mass serialisation may be the better solution. Whilst patients may be unaware about the true risk of drug counterfeiting, the pharmaceutical industry is far from ...
The World Health Organization is looking at ways to improve, and speed up, the approval of variations applications submitted under its pre-qualification programme that facilitates access to medicines meeting unified standards of quality, safety and ...
A significant number of European Economic Area member states are applying the variations regulation (Regulation No 1234/2008) to medicinal products authorised under purely national procedures, even though it is not mandatory for them to do so at ...
