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  • Feature ArticlesFeature Articles

    Establishing a Joint Venture Pharmaceutical Manufacturing Entity in Japan

    This article focuses on key regulatory activities to establish a Joint Venture (JV) for pharmaceutical manufacturing and sales in Japan. The author describes foundation building, marketing authorization holder responsibilities, new drug applications, clinical trial sponsorship, adverse events reporting and brand name registrations as well as requirements for data archiving and post-marketing regulatory activities. Introduction With the support of the Japanese Ministry...
  • Regulatory NewsRegulatory News

    Going Digital: EMA to Ditch Paper, Require Electronic Application Forms

    In an effort to reduce its administrative burden, the European Medicines Agency (EMA) will soon require companies to use electronic forms for a number of application types. The move is part of a wider effort in the EU to transition to international and electronic standards. Going Digital The process of transitioning to electronic systems can be complicated, especially for regulatory processes which are often highly complex.  However, electronic documents provide a num...
  • Feature ArticlesFeature Articles

    South Africa Medicines Regulatory System Overview

    South Africa’s medicines’ regulatory submission process is well governed, and there are numerous guidelines available, many following EU standards. The pharmaceutical regulating body in South Africa, the Medicines Control Council (MCC), is staffed to review a dossier completely to international standards, and it conducts its own review of the complete dossier, regardless of other major regulatory approvals (See Table 1 for MCC contact information). In ...
  • Regulatory NewsRegulatory News

    Australia’s TGA Issues Amended Nonclinical Studies Guidance

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Australia’s Therapeutic Goods Administration (TGA) this week (15 September 2014) issued  an amended guidance on nonclinical studies for Module 4 of the  Common Technical Document  (CTD), which is an integral part of an application to register a prescription medicine on...
  • Regulatory NewsRegulatory News

    FDA Looks to Improve Generic Drug Submission Quality in New Guidance

    The US Food and Drug Administration (FDA) has released a new draft guidance document on the content and format of generic drug submissions using the common technical document (CTD). Background Generic drug applications are regulated under Section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) , and are submitted to FDA using an Abbreviated New Drug Application (ANDA). A successful application will show that a drug is the same (as defined by FDA) as ...
  • In Landmark Vote, EU Passes New Clinical Trial Regulation, Including Data Transparency Measures

    • 02 April 2014
    • By
    The European Parliament (EP) today overwhelmingly passed new rules requiring pharmaceutical companies to make public the results of clinical trials, clearing the way for adoption of the rules in the EU later this year. The 2 April 2014 vote saw approval of the new rules by a margin of 594 in favor to 17 against, with 13 members of parliament abstaining. Background The vote comes after months of extensive debate and numerous delays, reflecting the broad scope of the pas...
  • EU Overhaul of Clinical Trials Directive Advances, Would Demand Full Data Transparency

    • 30 May 2013
    • By
    The European Parliament's (EP) Committee on the Environment, Public Health and Food Safety (ENVI) has endorsed and released a new draft rule regarding clinical trials for new medicines, saying the changes should result in "simpler, more uniform" rules and halt a five-year decline in clinical trials being conducted in the EU region. Background The rule was first called for in July 2012 by then-health commissioner John Dalli, who pointed to the 25% decline in EU clinical ...
  • FDA Signs onto ICH Guidance on E3 Guideline

    The US Food and Drug Administration (FDA) has released a new final guidance for industry explaining the E3 Structure and Content of Clinical Study Reports guideline , part of ongoing efforts by regulators to clarify some of the more common questions and answers about the longstanding guideline. The E3 guideline was approved by the International Conference on Harmonisation (ICH) in 1995, and adopted by FDA on 17 July 1996. It describes how sponsors can compile a ...
  • FDA Announces Adoption of ICH's Q11 Manufacturing Guideline

    The US Food and Drug Administration (FDA) has announced its adoption of the International Conference on Harmonization's Q11 guideline on the development and manufacture of biological and chemical drugs. The guideline, Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological Biological Entities , was released by ICH on 1 May 2012 for voluntary adoption by worldwide regulators. Explained FDA in its Federal Register posting announc...
  • Industry Pledges Tentative Support for Clinical Trials Data Transparency

    • 14 November 2012
    • By
    Greater transparency of clinical trials data has long been the goal of many academic researchers, who claim withheld data can often mask troubling safety issues. Now, those researchers are being joined by an unlikely ally: industry. Manufacturing giant GlaxoSmithKline made headlines in October 2012 when it announced it would shift to a new transparency model in which it would allow select researchers to access trials data. "Detailed clinical trial data to enable addit...
  • Incoming EU Health Commissioner Lays out Plan for Pharma, Medical Device Sectors

    • 09 November 2012
    • By
    The Commissioner-designate for the European Commission's Health and Consumer Protection agency, Tonio Borg, may not be scheduled to be sworn into office for some time, but he's already shedding light on how he plans to approach pending legislative and regulatory matters of importance to the pharmaceutical and medical device sectors. In remarks prepared for a legislative hearing before the Committee on the Environment, Public Health and Food Safety (ENVI), Borg, Malta's...
  • New EU Clinical Trials Proposal to Ease Pharmaceutical Industry's Concerns

    The European Commission (EC) has released a new proposal aimed at reforming Europe's pharmaceutical clinical trials regulations, dismantling an earlier attempt to modernize the rules and instead instituting an EU-wide harmonized approach. The new rules, previewed by European Commissioner for Health John Dalli at a 27 June meeting in Washington DC, will replace the 2001 Clinical Trials Directive (CTD) (2001/20/EC) once-or if-they are enacted in 2016. In a statement, ...