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

 
  • Regulatory NewsRegulatory News

    WHO Officials Offer Opposition to Value-Based Drug Pricing

    World Health Organization (WHO) officials told press in a briefing on Thursday that the agency has serious reservations with value-based pharmaceutical pricing. "What’s the value of life? This structure is good for luxury goods because you have a choice…if I’m sick with cancer, what’s the choice? We think value-based pricing is not feasible for products that are indispensable," Dr. Marie-Paule Kieny, assistant director-general of health systems and innovation at WH...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: TGA Plans to Bolster its Punishment Powers (9 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. NPPA Ratchets up Pressure on Abbott, Medtronic to Keep Supplying Stents The National Pharmaceutical Pricing Authority (NPPA) of India has stepped up its attempts to stop Abbott Healthcare and Medtronic from curbing supply of their high-end cardiac stents. NPPA’s latest move is to encourage hospitals, doctors and patients to tell it if there is a shortage of certain br...
  • Regulatory NewsRegulatory News

    EMA to Pharma Companies: Prepare for UK to EU Shift

    Setting the stage for a likely exodus from the UK for pharmaceutical manufacturers and staff, the European Medicines Agency (EMA) on Tuesday notified marketing authorization holders (MAHs) that for centrally authorized products, EU law requires them to be established in the EU or European Economic Area, which includes Iceland, Liechtenstein and Norway. EMA also notified MAHs that some of their activities must be performed in the EU (or EEA), related for example to ...
  • Regulatory NewsRegulatory News

    US Trade Report Highlights Pharma's IP, Counterfeit Issues Abroad

    The Office of the United States Trade Representative's (USTR) 2017 report on the state of intellectual property (IP) protection and enforcement in US trading partners around the world offers a look into concerns regarding market access barriers, particularly for those in the pharmaceutical and medical device industries. The report offers numerous examples of issues pharmaceutical and device companies deal with in some foreign countries, noting that these IP-intensi...
  • Regulatory NewsRegulatory News

    CDER Officials: Nanomaterial Submissions on the Rise

    A team of officials from the US Food and Drug Administration's (FDA) Office of Pharmaceutical Quality within the Center for Drug Evaluation and Research (CDER) say that submissions for drugs containing nanomaterials are on the rise. The finding stems from an analysis published Monday in Nature Nanotechnology , in which the officials look at trends in submissions involving nanomaterials over the last 40 years. In the analysis, the authors say the number of investigation...
  • Regulatory NewsRegulatory News

    MHRA Plans for the Future of Drug, Device Regulation Post-Brexit

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released a business plan for the upcoming year, noting its primary focus on developing a consensus around a proposed model for the future of the country’s regulation of medicines and medical devices following its departure from the EU. MHRA is pushing for a more international strategy that focuses on collaboration and engagement with key partners and stakeholders and continuing to partici...
  • Regulatory NewsRegulatory News

    FDA Hedges: A Proposal to Better Share R&D Risks

    The probability that an investigational drug will succeed in all three phases of clinical trials and win US Food and Drug Administration (FDA) approval is very low. So low, in fact, that a group of economists have written a new paper calling for a system whereby developers could hedge their research and development (R&D) risks by buying options that would pay companies a pre-specified amount in the event that a treatment fails a given phase of the FDA approval proce...
  • Regulatory NewsRegulatory News

    MHRA Investigates GMP Deficiency Trends From 2016

    The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Tuesday released a new report on the trends seen from inspecting pharmaceutical manufacturing plants and evaluating their good manufacturing practices (GMPs) in 2016. Compared to 2015, MHRA conducted 21 more total GMP inspections in 2016, and three more foreign inspections. But like in 2015, the most cited deficiency for 2016 was related to companies’ quality systems. Sterility assurance, producti...
  • Regulatory NewsRegulatory News

    House Bill Seeks to Expand Off-Label ‘Scientific Exchange’ Between Industry, Doctors

    While the US Food and Drug Administration (FDA) attempts to re-work its policy on off-label use communications, Rep. Morgan Griffith (R-VA) has introduced a new bill that would further allow pharmaceutical companies to discuss such uses with physicians. GOP representatives have criticized FDA recently for failing to update its policies on off-label use communications as the agency has lost several recent court cases on the issue , and has questioned the need for loos...
  • Regulatory NewsRegulatory News

    Drug Supply Chain Security: New APEC Toolkit to Aid Collaboration

    With the pharmaceutical supply chain becoming more global and complex, regulators, industry groups and academics from around the world have developed a new toolkit of resources to increase harmonization across borders to ensure the quality of drugs from manufacture through ingestion. The new toolkit, born out of a five-year collaborative project that actually took four years to complete, brings expertise from the US Pharmacopeial Convention (USP), US Food and Drug Admin...
  • Regulatory NewsRegulatory News

    Maryland House Passes Bill on Price Gouging of Generic Drugs

    Late Monday, Maryland’s House of Delegates signed off on a bill seeking to prohibit companies from overcharging for generic drugs. Under the bill, the Maryland Medical Assistance Program would be required to notify manufacturers of an essential generic drug and the attorney general of a specified increase in the price of the essential generic drug. The bill would also require a manufacturer of an essential generic drug to submit a specified statement to the attorney gene...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: UK Starts Risk-Based Inspections of Online Pharmacies (9 March 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Starts Risk-Based Inspections of Online Pharmacies After Finding bad Actors The United Kingdom has initiated a risk-based inspection program targeting online pharmacies and healthcare service providers. Officials at the Care Quality Commission (CQC) began the operation after urgent inspections of two digital providers of primary care and a review of 43 other services rais...