The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • RoundupsRoundups

    EU Regulatory Roundup: CHMP Questions Delay Novartis Gene Therapy Approval Timeline

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   CHMP Questions Delay Novartis Gene Therapy Approval Timeline   Tougher than expected regulatory scrutiny has delayed Novartis’ efforts to bring its spinal muscular atrophy gene therapy Zolgensma to patients in Europe. Novartis had hoped to win approval by the end of the year, but now expects the Committee for Medicinal Products for Human Use (CHMP) to deliver its op...
  • Regulatory NewsRegulatory News

    EMA’s CHMP Recommends First Ebola Vaccine, 6 Other Medicines

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced recommendations for seven new medicines for approval, including a conditional marketing authorization for Merck’s Ebola vaccine Ervebo (rVSVΔG-ZEBOV-GP, live), which is the first vaccine for those 18 years and older at risk of infection with the Ebola virus. EMA said that preliminary data suggest the vaccine is effective in the current Ebola outbreak in the De...
  • Regulatory NewsRegulatory News

    Novartis’ Zolgensma Joins Growing List of Medicines to Lose Accelerated Assessment Status in EU

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently announced its decision to remove Novartis’ spinal muscular atrophy gene therapy onasemnogene abeparvovec from its accelerated assessment program. CHMP did not announce its reasoning behind the decision, which effectively means that the treatment, approved in the US as Zolgensma and launched at a price of more than $2 million, will be reviewed in the EU in 210 days rather...
  • Regulatory NewsRegulatory News

    EMA Recommends First All-Oral Treatment for Sleeping Sickness

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced it has adopted a positive scientific opinion of Fexinidazole Winthrop (fexinidazole), the first oral-only medicine for the treatment of human African trypanosomiasis (HAT), commonly known as sleeping sickness.   This approval is a result of clinical trials led by the non-profit research and development organization DNDi, with an application submitted to EMA b...
  • Regulatory NewsRegulatory News

    EMA Backs Six Drugs, One Biosimilar for EU Approval

    The European Medicines Agency (EMA) on Friday said that its Committee for Medicinal Products for Human Use (CHMP) is recommending six new drugs, a biosimilar and three generic medicines for EU approval. The six medicines the agency is recommending are: Dr. Falk Pharma's Jorveza (budesonide) to treat eosinophilic esophagitis, a rare inflammatory condition of the esophagus. Jorveza was granted an accelerated assessment and orphan designation; Merck Sharp & Dohme's Pr...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: MHRA Chief Floats Faster Reviews, Closer Ties to NICE (19 October 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. MHRA Chief Floats Faster Reviews, Closer Ties to NICE as Post-Brexit Options for UK The head of the United Kingdom’s regulatory agency has sketched out some of the ways it may change after Brexit. Dr Ian Hudson stressed the UK wants a collaborative, ongoing relationship with the European Medicines Agency (EMA) but is preparing for the opportunities — and risks — that w...
  • Regulatory NewsRegulatory News

    EMA’s CHMP Adopts Updated Guideline on Manufacture of Finished Dosage Form

    The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) on Monday adopted an updated guideline on what manufacturing process information should be included in the marketing authorization application (MAA). The update, drafted in July 2015 , comes as there has been an increasing trend toward the outsourcing of manufacturing and more complex supply chains. The guideline "does not introduce new requirements" on authorized drugs, though t...
  • Regulatory NewsRegulatory News

    EMA Backs Eight New Medicines, Turns Down Drugs From Nektar & Vanda

    The European Medicines Agency (EMA) on Friday recommended the approval of eight new medicines after its Committee for Medicinal Products for Human Use (CHMP) met to discuss the drugs earlier this week. The agency also issued negative opinions for Nektar and Daiichi Sankyo's breast cancer drug Onzeald (etirinotecan pegol) and Vanda Pharmaceuticals' schizophrenia drug Fanaptum (iloperidone). Among the eight new medicines are five orphan medicines, including Santen Pharmac...
  • Regulatory NewsRegulatory News

    EMA Recommends New HCV, Cancer and MS Drugs for Approval

    The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended eight new medicines for approval, including two pan-genotypic hepatitis C (HCV) drugs and a third biosimilar for AbbVie's Humira (adalimumab). EMA says that both HCV drugs, AbbVie's Maviret (glecaprevir/pibrentasvir) and Gilead's Vosevi (sofosbuvir/velpatasvir/voxilaprevir), were given a speedy review under the agency's accelerated assessment mechanism. Bo...
  • Regulatory NewsRegulatory News

    EMA’s CHMP Recommends Approval for Five New Medicines, Four New Biosimilars

    The European Medicines Agency (EMA) met earlier this week and signed off on five new medicines, including one new advanced therapy, as well as four biosimilars and one generic drug. The advanced therapy CHMP recommended is Germany-based Co Don Ag’s Spherox (spheroids of human autologous matrix-associated chondrocytes), which is intended to treat adults who have a type of symptomatic articular cartilage defects in the knee. The four other new medicines were: Dom...
  • Regulatory NewsRegulatory News

    EMA to Continue to Allow Patient Involvement in CHMP Meetings

    The European Medicines Agency (EMA) said Monday that it will continue to allow patients to offer viewpoints during the assessments of the benefits and risks of medicines before its Committee for Medicinal Products for Human Use (CHMP). In addition to continuing to invite patients to oral explanations on a case-by-case basis, EMA will also look to use additional methods and consult patients on a more regular basis. "This could include participating in CHMP discuss...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Reviews Drugs Tested at Two Indian Sites (23 December 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. CHMP Starts Review of Drugs Tested at Indian Sites Amid GCP Concerns The Committee for Medicinal Products for Human Use (CHMP) has begun a review of drugs tested at two Micro Therapeutic Research Labs’ sites in India. National regulatory agencies asked CHMP to run a review after Austrian and Dutch authorities found fault with the sites during a good clinical practice (...