The four new consultations, released Thursday from the European Commission, deal with ethical considerations for pharmaceutical trials with minors, risk proportionate approaches in trials, summaries of trial results for non-specialists or “laypersons” and definitions of investigational medical products (IMPs) and use of auxiliary medicinal products (AMPs). The consultations offer respondents a chance to weigh in (comments on the four consultations are due by 31 August) o...

The European Parliament has voted to lessen the European Commission’s control of the structure and level of fees charged by the European Medicines Agency (EMA), which may instead be set by members of Parliament and European Union (EU) ministers. The amendment, which was proposed alongside a host of other amendments on fees and EMA-related structures linked to EMA’s founding regulation (No 726/2004), though any changes must be accepted by the EU Council of Ministers. “Me...

The complicated world of drug pricing presents an array of challenges for keeping costs low in the US and EU, though European countries are increasingly employing new policies to keep price gouging in check. The 260-page report on drug pricing in Europe, released Thursday by the European Commission, looks into two policy options: external price referencing (EPR), which is predominantly a tool for medicine price control and currently employed across the region, and differ...

This article provides a high-level introduction to the Chinese regulatory framework, including requirements for marketing approval of imported drugs. An increasing number of pharmaceutical companies based outside China are interested in marketing their products in China as evidenced by the increasing number of clinical trial and marketing applications submitted by foreign companies. Obtaining marketing authorization approval equal to an Import Drug License (IDL) approv...

Tomorrow and Friday, members of the World Trade Organization (WTO) will meet to discuss whether the world's poorest countries should be permanently exempt from rules governing pharmaceutical patents, and the EU and US have publicly taken separate sides. Background Since the initial WTO agreement on Trade-Related Aspects of IPRs (TRIPs) in 1995, least-developed countries (LDCs) have been granted exemptions from implementing intellectual property (IP) rules for pharmaceut...

Following two meetings with drug companies and other stakeholders in July and September, the European Medicines Agency (EMA) says it will publish the first clinical trial reports in mid-2016. The release of the reports comes as EMA's policy on publishing the data came into effect last January. The new policy applies to clinical reports contained in all marketing-authorization applications submitted on or after 1 January 2015, and includes reports where drugmakers hav...

The European Commission on Thursday agreed to support a proposal that would allow the least-developed countries (LDCs) to have easier access to generic drugs via an indefinite exemption from World Trade Organization (WTO) intellectual property rules for pharmaceuticals. The exemption, which must also be approved by the European Council, would allow generic drugs to be imported and manufactured locally, regardless of patents. More simply, the proposal means that manufactu...

The European Commission is seeking comment from industry on two documents tied to the guidelines and principles of good manufacturing practices (GMP) for investigational drugs. The commission notes that the current GMPs for medicinal products for human use from a 2003 directive are "generally well-functioning," so, "There is no need to reinvent the wheel." The application of GMPs for investigational drugs is intended to ensure that clinical trial subjects are not p...

The US Food and Drug Administration (FDA) recently announced it was considering changing the way homeopathic products are regulated and asked for input on whether its current regulatory framework for homeopathic products was sufficient. Now, the Federal Trade Commission (FTC) is weighing in, calling on FDA to "consider amending or repealing its framework for homeopathic medications." Background In March 2015, FDA announced a public hearing to evaluate its regul...

The Indian subsidiaries of two European drugmakers, GlaxoSmithKline (GSK) and Sanofi, have been fined for allegedly plotting to charge higher prices in a government tender for a meningitis vaccine, The Economic Times reports. Investigation and Allegations The Competition Commission of India (CCI) is tasked with enforcing The Competition Act , which "prohibits anti-competitive agreements, abuse of dominant position by enterprises," and oversees corporate mergers a...

Officials at the African Union Commission (AUC) and the World Health Organization Regional Office for Africa (WHO/AFRO) are looking to address the shortcomings of the international response to the Ebola crisis by launching a new disease monitoring agency, the Centres for Disease Control and Prevention in Africa (African CDC). Background Africa has the world's highest burden of disease , with far higher mortality rates for infectious diseases than any other region. Many...

Regulators at the German Federal Joint Commission (G-BA) have postponed their review of the gene therapy Glybera, Reuters reports . The decision was made after the European Medicines Agency (EMA) rapporteur assigned to Glybera found the product lacked efficacy and called for it to be reassessed. Glybera, which treats a rare condition called lipoprotein lipase deficiency (LPLD), made headlines both for being the first gene therapy approved in Europe and for its record-...