Category Archive
The following is a list of all entries from the regulatory category.
Drug Regulator, MHRA, Publishes an Updated Guide for Manufactures on Clinical Investigations to be Carried out in the UK
Filed in clinical, regulatory, January 6, 2010, 8:26 amThe Medical Devices Regulations 2002 (SI No 618), as amended by the Medical Devices (Amendment) Regulations 2008, came into force on 13 June 2002 and implement the provisions of the Medical Devices Directive 93/42/EEC (as amended by Directive 2007/47/EC), the Active Implantable Medical Devices Directive 90/385/EEC (as amended by Directive 2007/47/EC) and the In Vitro Diagnostic Medical Devices Directive 98/79/EEC. These Regulations establish systems under which a manufacturer must submit to the UK Competent Authority, information about clinical investigations of medical devices to be carried out in the UK.
Drug Regulators, EMEA, Publish Concept Paper on the Development of a Guidance on Similar Biological Medicinal Products Containing Monoclonal Antibodies
Filed in manufacturing, regulatory, December 27, 2009, 8:34 amMonoclonal Antibodies (mAbs) comprise a large important class of therapeutic biologicals. Different mAb products share some properties, e.g. on a functional level, but differ in aspects like the mechanism of action. The complexity of mAbs is a challenge for the development of new mAb products that are claimed to be similar to marketed mAbs. Nevertheless, such mAbs are being developed, and CHMP has given scientific advice for the development of some individual products.
Drug Regulators, EMEA, Publish ICH M2, Common Technical Document, Updated Q&A
Filed in business, licensing, regulatory, December 26, 2009, 11:04 amThis question and answer document is a summary of questions reviewed by the eCTD Implementation Working Group (IWG) on the eCTD Specification. The questions answered here relate to common questions that relate to the eCTD in all three ICH regions.
Drug Regulators Publish, ICH M2, Business Requirements Guidance
Filed in business, regulatory, December 25, 2009, 11:00 amICH M2 has initiated the development of the Next Major Version of the eCTD (eCTD NMV) to improve robustness, flexibility and long term stability of the message.
Drug Regulators, FDA, Publishes Guidance on Pharmaceutical Development Q8(R2)
Filed in manufacturing, regulatory, , 8:26 amThe Q8 parent guidance describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format.
Drug Regulators, EMEA, CHMP Publish Guidance on Follow-up Patients Adminstered with Gene Therapy Medical Products
Filed in biotechnology, clinical, regulatory, December 16, 2009, 11:25 amThe initial clinical monitoring and follow-up after treatment with Gene Therapy (GT) medicinal products is described in the CPMP Note for guidance on the quality, preclinical and clinical aspects of gene transfer medicinal products (CPMP/BWP/3088/99).
FDA Publishes Draft Guidance on E7 Studies in Support of Special Populations: Geriatrics Q&A
Filed in clinical, regulatory, , 11:19 amFDA Publishes Draft Guidance on E7 Studies in Support of Special Populations: Geriatrics Q&A full text available here
FDA Convenes Meeting Regarding Online Advertising
Filed in business, marketing, regulatory, December 12, 2009, 8:59 amAt a two-day meeting convened Thursday by the FDA, representatives from the pharmaceutical and other industries are gathering to give their opinions on how the US regulator should regulate advertising for drug products through the Internet and social media. The FDA agreed to consider formulating guidelines for online advertisements based on companies’ concerns that regulations for traditional media, particularly those involving the disclosure of side effects, may not be appropriate for the Internet.
MHRA Re-Publish Guidance On How they Regulate Traditional Herbal Medicines (THMRS)
Filed in Herbal, regulatory, December 9, 2009, 8:20 amManufactured herbal medicines1 placed on the UK market are required to have either a Traditional Herbal registration (THR) or a Marketing Authorisation (MA). This applies whether the product is marketed to consumers, herbal practitioners, retailers, or wholesalers. There is one principal exception in relation to herbal medicinal products. Where a manufactured herbal remedy meets both the following requirements
MHRA puts new Traditional Herbal Medicines Registration Scheme Page Live
Filed in Herbal, regulatory, December 8, 2009, 8:19 amThis new section has been specifically created to provide practical guidance to help those operating within the herbal medicine sector to understand and comply with the Traditional Herbal Medicines Registration Scheme (THMRS), as required by Directive 2004/24/EC on Traditional Herbal Medicinal Products.
