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  • Regulatory NewsRegulatory News

    With Drug Shortages in Mind, UK Looks to Block Some Parallel Exports

    As part of efforts to prevent drug shortages ahead of a possible no-deal Brexit, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday published a list of 24 medicines that cannot be parallel exported from the UK. The list includes drugs like the hormone therapies estradiol and levonorgestrel, the antiviral oseltamivir, adrenaline, the blood thinner rivaroxaban and the high blood pressure medicine prazosin, among others. The reason why the UK...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Proposes Sourcing Requirements for Drug, Device Companies (3 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Proposes Sourcing Requirements for Drug, Device Firms as Traceability Agenda Gathers Pace The China Food and Drug Administration (CFDA) has released another piece of its proposed strategy for implementing a traceability system across the country. In the latest text, the regulator has set out plans to make drug manufacturers assess the quality of their raw material sup...
  • Regulatory NewsRegulatory News

    EMA Launches Parallel Distribution Database

    To boost transparency for re-exported drugs, the European Medicines Agency (EMA) has created a new publicly available online register for parallel distribution notices. Background Parallel distribution, often referred to as re-exportation, allows companies in the EU to distribute centrally authorized medicines between member states, independent of their marketing authorization holder. This practice makes it possible for cheap drugs in one Member State to be distributed ...
  • FDA Moves to Close Glaring Loophole in Current Drug Import System

    A proposed rule issued by the US Food and Drug Administration (FDA) would make it easier for the agency to destroy low-value drugs refused admission into the US under federal law. Background: Import Regulation The backbone of pharmaceutical regulation in the US is the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under Section 801(b) of the FD&C Act , FDA is permitted to refuse to allow the import or entry of any drug that has not been approved (under Sect...
  • Feature ArticlesFeature Articles

    Debarred, Denied, Restricted? Legal Responsibilities in Outsourcing

    • 29 April 2014
    • By
    Regulatory professionals frequently work with their supply chain colleagues to ensure all relevant documentation is provided for the export of goods from the country of origin. However, there are little-known US regulatory requirements with potentially significant administrative and criminal consequences for violation, and many manufacturers may not be aware of them. The US Departments of Commerce, State and the Treasury publish lists of US and international individuals a...
  • CDSCO Clarifies the Role of its International Unit

    India's Central Drugs Standard Control Organization (CDSCO) has posted the organizational structure and functions of its recently-formed International Cell , which interfaces with foreign governments and regulatory agencies and investigates reports of quality concerns with India drug exports.  Among its other functions, the Cell focuses on bilateral Memoranda of Understanding (MOUs), grants written confirmations for active pharmaceutical ingredient (API) exports f...
  • Feature ArticlesFeature Articles

    Document Authentication for Product Registration/Regulatory Submissions Outside the US

    • 01 August 2013
    • By
    Have you ever opened your email to find a message that contained something like: "This CFG/CFS/CPP/COE 1,2,3,4 must be apostilled 5 for Russia"? "These ISO certs 6 need legalization (or consularization) from the Consulate of Brazil"? Either you are very familiar with these requirements or, particularly if your company is relatively new to foreign markets, you have no idea what these terms mean. It's important to know that when engaged in marketing its medical...
  • Corrected: CFDA Issues API Export Instructions to Provinces

    China's Food and Drug Administration (CFDA) last week issued instructions to Chinese provinces regarding the requirements for certifying active pharmaceutical ingredient manufacturers for the right to export their products to the European Union (EU) as of 2 July 2013. Editor's Note: A previous iteration of this article said that the ingredients in question were excipients. They are in fact APIs. We regret the error. The announcement, made on 7 May 2013 and issued w...
  • Brazil Establishes Contingency Process for Dealing With EU API Export Rules

    Under a new plan announced by Brazil's regulatory agency, Anvisa, even if Brazil fails to obtain EU recognition for its active pharmaceutical ingredient (API) good manufacturing practice (GMP) standards by the mandatory date of 2 July 2013, regulators will still provide Brazilian companies with a document indicating GMP compliance so facilitate exports of their APIs. The Falsified Medicines Directive (Directive 2011/62/EU) was adopted in May 2011 to safeguard public he...
  • Medical Device Export Certificate Process Going Digital, FDA Announces

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has announced the launch of a new electronic submission process for requesting export certificates for products it regulates, calling it a "win" for both the agency and industry. Background In 1996, Congress passed the FDA Export Reform and Enhancement Act ( FDERA ) of 1996. The law was intended to clean up the reputations of medical device manufacturers and US exports by req...
  • EU Falsified Medicines Directive Could Result in Drug Shortages

    The European Heads of Medicines Agencies (HMA) has notified the European Commission of its "deep" concern that the implementation of the Falsified Medicines Directive (2011/62/EU) will lead to possible shortages of medicinal products with resulting risks to public health.   The Directive, which goes into effect on 2 July 2013, requires all imported active pharmaceutical ingredients (APIs) to be manufactured in compliance with the standards of good manufacturing pr...
  • Facing Shortages, Greece Bans Export of Drugs

    • 24 October 2012
    • By
    Greece is one of many countries, including the US and Canada, currently experiencing shortages of numerous drugs. But unlike other countries, Greece, which is in the midst of an economic crisis, has taken a novel and potentially controversial approach to solving the problem: it will no longer allow the export of pharmaceutical products from the country. Reuters reports the country's shortages are mainly the result of price slashing that the country has been forced ...