November 2013: On 8th October 2013 the European Parliament rejected a proposal to class electronic cigarettes as medicinal products on a compulsory basis. The final form of the Tobacco Products Directive is currently subject to negotiations that are taking place between the European Commission, the Council of Member States and the European Parliament. It is anticipated that a further vote on the final form of the Tobacco Products Directive will take place in early 2014. Currently, the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) is encouraging manufacturers to apply for Marketing Authorisation for their electronic cigarettes as medicinal products under existing medicines legislation, for which a medical indication will need to be substantiated (i.e. harm reduction and/or aid to quitting smoking). Whilst a decision to pursue a medical indication is currently voluntary, the MHRA is trying to encourage manufacturers by offering free scientific advice.
Spectrum can help manufacturers to understand both the current and the anticipated new regulatory landscape, to interact with the MHRA to determine the regulatory path to approval, and to establish valuable and differentiated brand claims in both registered medicinal and consumer markets. At this time, manufacturers seeking a voluntary Marketing Authorisation from the MHRA may benefit from some flexibility in the application of the regulations, as well as gaining a competitive advantage. A medicinal claim can increase brand value and commercial leverage within the market.
October 2013: The EMA has released the first qualification opinion on a statistical methodology for dose finding for public consultation. The methodology, Multiple Comparison Procedure – Modelling (MCP-Mod) assists with both the design and analysis of dose-finding studies. The draft opinion considers that the methodology could promote better design and analysis of trials. The deadline for comments is 24th November 2013.
October 2013: The Court of Justice of the EU has ruled that a product may be classified in a device in one country and as a medicinal product in another. This will lead to large differences in the way what is essentially the same product, would be regulated. In addition, the Court has ruled that a product classed as a medicine could be marketed as such in a country alongside the same product classed as a device. This ruling came after the Finnish Supreme Administrative Court requested a preliminary hearing by the court following a decision by the Finnish National Agency for Medicines to re-classify a medical device (available in Finland, Spain, Italy, France and Austria) as a medicine.
October2013: The European Medicines Agency (EMA) has announced that the newly released version of the European Clinical Trials Database (EudraCT), V9, marks the first step in the process of making clinical trials results available to the public through the EU Clinical Trials Register (EU CTR). Sponsors are being encouraged to use EudraCT not only to register the protocol of the clinical trial, but also the results, which would then become available to the public once the new version of the EU CTR is launched later this year.
October 2013: The Electronic Submission Roadmap aims to establish a secure, consistent and efficient electronic submission process for medicinal products across the EU. It intends to define the way in which regulatory information is submitted, received, validated, processed and distributed, leading to a more harmonious process across Europe. A survey has been launched to determine the feasibility. The deadline for comments is 31st October 2013.
October 2013: The Scottish Health Secretary has announced a series of measures aimed at increasing the transparency of Scotland’s drug approval process. The Scottish Medicines Consortium (SMC) will conduct a review to establish more flexible approaches enabling access to medicines for very rare conditions and end-of-life care. Other measures include, extension of the Rare Conditions Medicines Fund, improved patient engagement in the drug approval process, additional investment in the SMC to increase transparency, a new peer approval system to allow clinicians to prescribe medicines which are not accepted for routine use by the SMC, and an opportunity for the SMC to appraise new medicines not yet submitted by the manufacturers if they are considered to be clinically important to NHS Scotland.
October 2013: The draft regulation put forward by the European Commission for the revision of the Tobacco Products Directive to regulate electronic cigarettes as medicines was not supported by MEPs. The majority of MEPs supported regulation through a hybrid of the tobacco regulation (i.e. promotion) and medicines style regulation (i.e. adverse event reporting). The MHRA has stated that it continues to believe that the best way to deliver public benefit is through medicinal regulation, and is continuing to encourage companies to seek a license for their products so that they can be seen to meet appropriate safety, quality and efficacy criteria, and used in accordance with the National Institute for Health and Care Excellence guidelines.
October 2013: The inverted triangle used for some years in the UK to aid monitoring of new medicines is now in use across Europe. Patients will see the black triangle in the patient information leaflet of some medicines, along with information on how to report suspected adverse events, and a description of what the triangle means.