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  • Regulatory NewsRegulatory News

    EMA Adds New Excipients to Labeling Requirements

    The European Medicines Agency (EMA) on Monday updated its annex to the European Commission's guideline on excipient labeling, adding five new excipients and expanding the safety warnings required for 10 others. Excipients are defined as any part of a drug other than the active pharmaceutical ingredient. Most excipients are thought to be inactive, though some can cause reactions in certain circumstances. For instance, lactose is commonly used as a filler in drug tablets, ...
  • Regulatory NewsRegulatory News

    EC Unveils Revised Guideline on Pharmaceutical Excipients

    The European Commission on Tuesday opened for public comment a revised guideline concerning the list of excipients, defined as any constituents of a medicinal product other than the active substance and the packaging material, which must be included on the labeling of medicines, as well as the way in which these excipients must be indicated.  The guideline’s revision, which the EC says reflects developments since 2003, includes a list of excipients which should be state...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: GPs Create Expert Group to Liaise With EMA (5 May 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Posts Draft Guideline on Clinical Trials of Acute Coronary Syndrome Treatments The European Medicines Agency (EMA) has released a draft guideline about the clinical development of treatments for acute coronary syndrome (ACS). EMA drafted the text to update a pair of existing guidance documents, which have been rendered outdated by advances in the diagnosis, treatme...
  • Regulatory NewsRegulatory News

    EMA Clarifies How to Include API Mix Data in a Marketing Application

    API mixes, which are mixtures of one or more excipients and an active pharmaceutical ingredient, are used to improve the safety, stability or workability of an active ingredient. Some examples of commonly used excipients for these purposes include antioxidants, preservatives and diluents. EMA says it considers the mixing process "to be the first step of the manufacture of a finished product." As such, sponsors are required to submit information about the mixture just as ...
  • Regulatory NewsRegulatory News

    French Regulators Find Cargill Manufacturing Site Non-Compliant With GMPs

    France’s National Agency for Medicines and Health Products Safety (ANSM) has uncovered deficiencies at Cargill’s manufacturing site in Lannilis, France that have resulted in a major recall. The release of the July inspection report on 30 October detailing Cargill's violations follows a s previous decision issued by ANSM on 25 September to suspend the manufacturing, packaging, licensing, distribution, exportation and the use of active ingredients and excipients manufactur...
  • China: SFDA Issues New Draft Excipient Rules

    China's State Food and Drug Administration (SFDA) issued draft rules on 4 June to require pharmaceutical manufacturers to establish a system of ensuring the quality of the excipients they use in their drug production. Under the draft guidelines, drug manufacturers will explicitly have the primary responsibility to assure the quality of the excipients that they obtain from their excipient suppliers. The goal of the draft rules is to "realize the full supervision of the...
  • China: New Draft Rules On Excipients

    China's State Food and Drug Administration (SFDA) issued draft rules on 4 June that would require pharmaceutical manufacturers to establish a system of ensuring the quality of the excipients they use in their drug production.  The draft establishes drug manufacturers as having the primary responsibility to assure the quality of excipients obtained from suppliers The goal of the draft rules is to "realize the full supervision of the pharmaceutical production and s...
  • Brazil: New Quality Standards for Excipients

    Brazil's national regulator, Anvisa, will open a public consultation on establishing quality requirements for pharmaceutical excipients used in the manufacture of medicinal products. Excipients include additives such as diluents, flavoring agents and antioxidants. The  Public Consultation No. 31 , published 28 May, provides for 60 days of comment beginning June 4 2012.  Comments can be submitted using the Ministry of Health's electronic system, FormSUS. Rea...
  • EMA Releases Concept Paper on Excipient Labeling

    The European Medicines Agency (EMA) released a concept paper on 8 March about the need to revise current labeling guidelines for medicines containing excipients . Current guidelines contain warnings about the presence of certain excipients, particularly those pursuant to 2001/83/EC Article 54(d) which states that all excipients must be declared if a product is an injectable product or eye preparation. Further, all excipients know to have an action or effect on the body ...