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This section offers regulatory news briefs as of November 3, 2014. The Government of Canada has approved transparency amendments in a proposed patient safety law named Vanessa's Law (Bill C-17). The U.S. Food and Drug Administration (FDA) has launched openFDA, an initiative aimed at facilitating public access to large public health datasets collected by the agency. The FDA has outlined expectations for the implementation of compounding provisions enacted into law in November 2013.

The article presents 2012 and 2013 news on regulatory action related to drugs. The U.S. Food and Drug Administration has announced that it is forming an internal task force to support development of new antibacterial drugs. Great Britain's National Institute for Biological Standards and Control will become a part of the Medicines and Healthcare products Regulatory Agency on April 1, 2013. The government of Pakistan enacted the Drug Regulatory Authority of Pakistan bill on November 12, 2012.

This section offers pre-marketing evaluation news briefs for the healthcare sector. The European Medicines Agency (EMA) started its adaptive licensing approach project, which seeks to enhance timely access to new drugs for patients. The EMA approved a partnership with the Australian Therapeutic Goods Administration to disclose full assessment reports on marketing approvals of orphan drugs provided in parallel to both agencies.

The article reports that the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) has confirmed that acipimox should only be used in European Union (EU) when diet, exercise, and treatment with other medicines are not adequate.

The article discusses the good manufacturing practice (GMP) compliance data of Japanese manufacturers that are being entered into the EudraGMDP database, an initiative between the Japanese Ministry of Health, Labour and Welfar (MHLW) and the European Medicines Agency's (EMA) Pharmaceuticals and Medical Devices Agency (PMDA) which aims to speed up regulatory procedures and save time for importers, manufacturers and regulatory authorities. It references the EMA Press Release on October 7, 2013.

The article discusses the European Medicines Agency's (EMA) version of the European Clinical Trials Database, EudraCT V9, marking the first step of a process through which summary clinical trial results will be available to the public through the EU Clinical Trials Register (EU CTR).

The article reveals that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved the granting of a conditional marketing authorization for bedaquiline (Sirturo) for the treatment of pulmonary multidrug-resistant tuberculosis in adults.

The article discusses the recommendation by the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) to grant marketing authorization for sofosbuvir (Sovaldi) for use in combination with other medicinal products for the treatment of chronic hepatitis C (HCV) in adults.

The article discusses the recommendation by the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) to grant a marketing authorization for dolutegravir (Tivicay) in combination with other antiretroviral medicines for HIV treatment of adults and adolescents over 12 years.

The article reports on a 2013 decision which the European Medicines Agency’s Committee for Medicinal Products for Human Use made to give marketing authorization for the drug dabrafenib, which is used to treat metastatic melanoma.

The article reports on a 2013 decision which the European Union's Committee for Medicinal Products for Human Use made to recommend granting a conditional marketing authorization for the drug vismodegib, which is used to treat symptomatic metastatic basal cell carcinoma.

The article reports on a 2012 notification which the European Medicines Agency received from the manufacturer of the drug lapatinib regarding the manufacturer's decision to withdraw its application for a centralized marketing authorization for the drug.

The article reports on a 2011 announcement from the European Medicine Agency's Committee for Medicinal Products for Human Use which suggested that the benefits of nimesulide-containing medicines outweigh the risks and that they should not be used for the symptomatic treatment of osteoarthritis.

The article reports on a 2011 decision which the European Medicines Agency made to approve the drug Euratesim, which is used to treat uncomplicated Plasmodium falciparum malaria in adults, children and infants aged 6 months or over.