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  • Regulatory NewsRegulatory News

    EMA nominates executive director to replace Rasi

    The European Medicines Agency’s (EMA) Management Board on Thursday nominated Emer Cooke from a short list of candidates to succeed Guido Rasi as the agency’s next executive director.   Rasi, whose second term as EMA executive director ends on 15 November, served as Executive Director from 2011-2014 before being forced to step down after the European Union Civil Service Tribunal annulled his appointment. (RELATED: Rasi returns to head EMA for five-year term , Regula...
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    Danish Medicines Agency Ramps Up Capacity in Medical Devices

    The Danish Medicines Agency's Medical Devices Unit is “massively building up capacity” in the area of medical devices, the agency said Tuesday, to better deal with the incoming EU device legislation and to address rapid changes in technological development. A new fee structure will allow the devices unit to increase its staff capacity from about 14 employees to about 40 employees once all new employees have been recruited next spring. The unit will also work more closel...
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    EMA Launches Operations in Amsterdam

    The European Medicines Agency (EMA) on Monday kicked off operations at its temporary premises at the Spark building in Amsterdam Sloterdijk after moving out of its Canary Wharf office in London on 1 March.   EMA says it is also working with Dutch authorities to finish readying its temporary premises ahead of 30 March, when the agency’s seat officially switches from London to Amsterdam.   “By Monday 18 March, when EMA will be settled in the Spark building, close to ...
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    EMA Expands Online Portal for Parallel Distribution Submissions

    The European Medicines Agency (EMA) on Monday announced that going forward, parallel distributors will be required to use its recently launched secure online portal, known as Iris, to manage and submit parallel distribution notifications.   Background   Parallel distribution, also known as re-exportation, is a process by which companies in the EU distribute centrally authorized medicines between member states, independent of their marketing authorization holder (...
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    European Commission Consults on Orphan Drug Applications

    The European Commission on Tuesday launched a targeted consultation to provide input on a revision of its guideline on the content and format of applications for orphan drug designation, as well as the transfer of designations between sponsors.   "The comments received will be taken into account by the European Commission in the finalization of the guideline on the format and content of application for designation as orphan medicinal products and on the transfer of des...
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    EMA Sartan Investigation Flags Aurobindo Pharma, Raises Zhejiang Huahai Oversight

    The European Medicines Agency (EMA) announced Monday low levels of a probable human carcinogen have been detected in a third sartan made the second India-based company—Aurobindo Pharma—to have been linked to the international valsartan scandal.   The notice follows on the heels of the EMA’s decision to extend its review to include medicines containing an additional four sartans, with the one impacted by the suspension of Aurobindo Pharma’s European certificate of s...
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    EMA to Raise MAH and Applicant Fees by 1.7% in April

    As part of the European Medicines Agency’s (EMA) alignment with the inflation rate, the agency announced on Tuesday that general, non-pharmacovigilance for applicants and marketing authorization holders are increasing by 1.7% on 1 April 2018. “All applications received by 31 March will be charged the current fee and reduction rates. Applications received after that date will be charged the adjusted fees,” EMA said. “For scientific advice and protocol assistance, the cut...
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    Italian Medicines Agency Cites Brazilian Drugmaker for GMP Violations

    The Italian Medicines Agency (AIFA) has banned the supply of certain drugs made by Antibioticos do Brasil (ABL) following an inspection of the company's San Paulo, Brazil facility in December. In total, AIFA cites the company for four critical and seven major deficiencies, including inadequate maintenance and cleaning; poor levels of training and awareness of good manufacturing practices (GMP); and insufficient environmental monitoring. As a result of the findings, AIFA...
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    Danish Regulator Suspends Parallel Importer's GMP Certificate

    The Danish Medicines Agency has suspended Danish parallel importer Europharma DK's manufacturing authorisation and good manufacturing practice (GMP) certificate over "serious breaches of compliance" uncovered during an inspection of the company's Esbjerg, Denmark site last month. According to Europharma DK's website, the company specializes in parallel import of drugs from other EU countries that it repackages and distributes in Denmark, Germany and Sweden. However, the...
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    Italian Medicines Agency Uncovers Deficiencies at Two Indian Drug Plants

    The Italian Medicines Agency on Wednesday released two statements of non-compliance with regard to good manufacturing practices (GMPs) for Visakhapatnam, India-based Krebs Biochemicals & Industries and Daund, India-based JP Laboratories. At the Krebs facility, the Italian regulators uncovered 24 deficiencies, five of which were classified as major. “The combination of the findings demonstrated a critical risk to public health, as the weaknesses of the company’s qua...
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    Swedish Regulators Find Capsugel’s Oregon Site Not GMP Compliant

    Sweden’s Medical Products Agency (MPA) declared Monday that Capsugel subsidiary Bend Research’s Oregon manufacturing site does not comply with Europe’s good manufacturing practice (GMP) requirements. The statement of non-compliance follows a 24 February inspection of the site, which uncovered non-compliant operations with regard to non-sterile products, packaging and quality control testing. The inspection also found two critical, seven major and 12 other deficiencies ...
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    Dramatic Drop in Hydrocodone Combo Prescriptions After DEA Rescheduling

    Prescriptions for hydrocodone combination products (HCPs) fell significantly after the US Drug Enforcement Agency (DEA) tightened restrictions on those drugs, according to a study published Monday in JAMA Internal Medicine . For years the US has been in the grips of a prescription drug abuse epidemic, in part driven by the availability of hydrocodone and other opioids such as oxycodone, codeine and methadone. In 2013, more than 200 million prescriptions for opioids we...