International Pharmaceutical Regulatory Monitor
April 2012 | Vol. 40 No. 4 | Full Issue in PDF Format
The European Medicines Agency (EMA) is increasing restrictions on the activities of its scientific experts and committee members in an updated conflict-of-interest policy that took effect March 4, less than a year after the last set of updates.
The chair of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) resigned April 4, effective immediately.
Sponsors, clinical research organizations (CRO) and clinical investigators should have an easier time determining what drug development data in an EU marketing authorization is destined for public consumption, thanks to a new European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) joint guidance.
Sponsors would submit one clinical trial application in the EU via a single portal, under a streamlined assessment process advocated by the European Commission (EC).
Roughly 8 percent of clinical trials inspected by Health Canada between 2004 and 2011 failed to comply with agency regulations, according to a new report.
Drugmakers should provide separate estimates of cumulative and interval patient exposure to marketed drugs and provide justification when an estimate of the number of patients exposed can’t be obtained, according to an International Conference on Harmonisation (ICH) draft guideline on periodic benefit-risk evaluation reports (PBRER).
Companies seeking to market biosimilars may have more success getting their products approved in the U.S. than in other highly regulated markets, thanks to “step-wise” guidance developed by the U.S. Food and Drug Administration (FDA) and released in February.
Patent reform legislation approved by the Australian Parliament March 20 establishes a higher standard for assessment of invention and innovative steps, provides for a new “utility” requirement that requires “specific, substantial and credible use” for a claimed invention and includes more stringent requirements for the scope and detail of disclosure required to support patent claims.
Singapore’s Health Sciences Authority (HSA) and Malaysia’s National Pharmaceutical Control Board (NPCB) will exchange drug registration assessment reports and conduct joint inspections of manufacturing plants, under a March 27 memorandum of understanding.
Members of the East African Community (EAC) and public and private international aid organizations March 30 launched an initiative to promote harmonization of drug registration in Kenya, Uganda, Tanzania, Rwanda and Burundi.
A Medicines and Healthcare products Regulatory Agency work group is developing proposals for streamlining the UK’s over-the-counter drug reclassification process, and plans to release updated guidance on the subject later this year, according to an MHRA report. Includes the full text of MHRA's Fifth Report on Better Regulation of Medicines Initiative.
Sen. Richard Blumenthal (D-Conn.) March 29 called the U.S. Food and Drug Administration’s (FDA) response to drug shortages “inadequate,” saying lawmakers need to give the agency more tools and mandates to correct the issue.
In the U.S. Senate’s second action in a week aimed at strengthening the pharmaceutical supply chain, the Judiciary Committee March 9 approved a bill that increases penalties for stealing prescription drugs and other medical products.
Drug manufacturers and authorized distributors have until at least October to comply with a 2010 Affordable Care Act provision that requires submission of drug sample information to the U.S. Food and Drug Administration (FDA) by April 1 of each year.
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