• Feature ArticlesFeature Articles

    Getting to the point: Achieving clear communication with health authorities

    This article discusses the critical need for clear, precise, and consistent communication on the part of regulatory professionals in interactions and submissions with health authorities. It presents various approaches and offers examples for the regulatory professional to draw on to improve the clarity of such communications.   Introduction As a regulatory professional, one is constantly reaching for and achieving new goals. Whether it is initiation of a first-in-hum...
  • Regulatory NewsRegulatory News

    Half of Clinical Trials Fail to Publish Results, UK Report Finds

    Despite UK and EU rules aimed at boosting clinical trials reporting and transparency, a new report by the UK House of Commons’ Science and Technology Committee finds that nearly half of clinical trials fail to publish results.   “Around half of clinical trials are currently left unreported, clinical trial registration is not yet universal in the UK and reported outcomes do not always align with the original study proposal,” the report finds.   Based on these findin...
  • Regulatory NewsRegulatory News

    European Commission Adopts Two Acts on GMPs for Medicines

    Last month, the European Commission adopted two legal acts seeking to improve patient safety through good manufacturing practices (GMP) that ensure the highest quality of medicines for investigational and human use. One of the acts is an  implementing directive  that sets out principles and guidelines of GMP in medicines where the manufacture or import is subject to a manufacturing authorization ( see Article 40 of the Community code Directive (2001/83/EC) ). The ...
  • Feature ArticlesFeature Articles

    Medicinal Product Registration in Egypt

    This article provides an overview of Egypt's New Drug Application (NDA) procedure for imported brand pharmaceutical products, including new chemical entities and biologics. It discusses the various Egyptian Drug Authority (EDA) departments and the required procedures for moving products through registration and into the market. Introduction Egypt, with more than 92 million inhabitants, is the most highly populated nation in North Africa and the Arab world. It is the t...
  • Feature ArticlesFeature Articles

    Drug Regulatory Authority of Pakistan: Organizational Structure, Functions and Future Challenges

    This article discusses the development of a more effective pharmaceutical regulatory environment in Pakistan through the establishment of a regulatory agency designed to address current good manufacturing practices and quality management systems for drug production to improve the availability, accessibility and affordability of drugs. Introduction and Background As regulatory bodies continue to stress the need for standardizing current Good Manufacturing Practices (cG...
  • Regulatory NewsRegulatory News

    House Bill Seeks to Add Mandatory Drug Recall Authority to FDA’s Arsenal

    Rep. Rosa DeLauro (D-CT) on Thursday introduced a new bill that will allow the US Food and Drug Administration (FDA) to do what many assume it already can: Require pharmaceutical or over-the-counter drug companies to stop marketing unsafe products. The Recall Unsafe Drugs Act would give FDA mandatory recall authority over drugs and homeopathic products. The agency confirmed to Focus that it does not have that authority. The loophole is problematic in that some compani...
  • Feature ArticlesFeature Articles

    Strategic Regulatory Considerations for Early Medical Device Consultations with Global Regulatory Authorities

    This article discusses the early consultation process for medical devices in the EU and US and key considerations when planning such a meeting. Developing a Global Strategy for Early Consultations Are you developing an innovative medical device? Does it employ a novel technology? Does it provide novel diagnostic information or therapeutic benefit? Is it a combination or borderline product or a companion diagnostic? Do your plans to demonstrate safety, performance and/...
  • Regulatory NewsRegulatory News

    Saudi Regulators Issue New Guidance on Investigational Medical Devices

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Saudi Food & Drug Authority (SFDA), the Kingdom of Saudi Arabia’s medical device market regulator, has published new guidance on requirements for conducting clinical investigations in the country. According to the  guidance , all clinical investigations planned to take place in the KSA must obtain SFDA approval; all investigational me...
  • Regulatory NewsRegulatory News

    Company Challenges UK Clinical Trial Transparency Rules

    An initiative to increase clinical trial transparency in the UK is being challenged in court after a successful petition by a company that conducts clinical trials for the pharmaceutical companies, The Guardian reports. Background The Health Research Authority (HRA) is a recently launched branch of the UK's National Health Service (NHS), tasked with overseeing clinical research and making recommendations on how research is regulated. While HRA's main mandate is ...
  • Regulatory NewsRegulatory News

    India Looks to Cap Prices of 12 Cancer Drugs as Nation Looks to Expand Price Controls

    The cost of 12 cancer drugs could soon be capped in India if a recommendation from the country's National Pharmaceutical Pricing Authority (NPPA) is approved, The Indian Express reports. At the same time, the government is actively looking into revising its National List of Essential Medicines (NLEM) following a proposal from a parliamentary committee for price caps to be extended to all drugs two weeks ago. Background In India, the prices of drugs listed under t...
  • Regulatory NewsRegulatory News

    Indian Parliament Proposes Extending Price Caps to all Drugs

    Just weeks after India's drug pricing chief was ousted, a parliamentary committee has proposed expanding price caps to all drugs. Background In India, the price of drugs listed as essential medicines is capped by the National Pharmaceutical Pricing Authority (NPPA) under the country's Drug Price Control Order (DPCO) . The amount these drugs can be sold for is indexed to average wholesale prices of similar products, and can only be increased once per year, as was th...
  • Regulatory NewsRegulatory News

    New Guidance Clarifies Saudi Labeling Requirements for Medical Devices

    Content provided by  Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Saudi Food & Drug Authority (SFDA) has issued new guidance on labeling requirements for medical devices approved for sale in the Kingdom of Saudi Arabia (KSA). The guidance  clarifies labeling rules previously included in the Saudi Medical Devices Interim Regulation more so than adds any new or altered requirements. Among the key clarifi...