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Europe -
CEP document revised: “Implementation of ICH Q3D in the Certification Procedure”

The EDQM document “Implementation of ICH Q3D in the Certification Procedure” has been revised based on experience gained by EDQM since the initial implementation of the policy. Its implementation date is the 1st September 2018 ...

l’industrie pharmaceutique ne veut pas cautionner la peine de mort

Afin d’appliquer la peine de mort, le Nevada a opté pour un nouveau "cocktail" létal, associant du Fentanyl et deux autres molécules dont un hypnotique, le Midazolam, commercialisé aux États-Unis par le laboratoire Alvogen. Ce mercredi, l’exécution de Scott Dozier, alors qu’il était déjà installé et prêt à subir sa peine, a été suspendue sine die, la firme pharmaceutique venant de déposer une plainte contre l’État, en lui reprochant de s’être procuré « frauduleusement » le médicament, puisque il n’avait pas informé la compagnie de l’utilisation future du produit. Or, l’avocat d’Alvogen estime...

France -
Prévention contre le sida : trois ans de retard

Retour sur le rapport de l'Inspection générale des affaires sociales qui met en cause les lenteurs de l'administration dans l'arrivée de la Prep en France. 1 600 à 4 000 contaminations auraient pu être évitées selon les auteurs. D’ordinaire, les rapports de l’Inspection générale des affaires sociales (Igas) restent diplomatiques. En tout cas, ils ne dépassent pas une relative bienséance qui convient aux relations (même quand elles sont tendues) dans l’administration française. Le rapport rendu public la semaine dernière sur le Truvada, traitement préventif contre le VIH (prophylaxie pré-...

Europe -
EMA Report: Clinical Data Published on 50 Medicines in One Year

The European Medicines Agency (EMA) on Monday published its first report on implementing its policy on the publication of clinical data whereby researchers, academics and others can access data from clinical reports submitted by pharmaceutical companies to EMA for new medicines as of 1 January 2015. The 27-page report covers one year from the launch of EMA’s clinical data website on 20 October 2016, and lists the 50 medicines for which clinical data were published, including orphan (9), pediatric (6), biosimilar (1) and generic (12) medicines, as well as the corresponding 54 regulatory...

International -
Following EU Recalls, FDA Announces Voluntary Recall of Drugs Containing Valsartan

Earlier this month, the European Medicines Agency (EMA) initiated recalls of certain valsartan-containing medicines with active substance supplied by China-based Zhejiang Huahai Pharmaceuticals, pending a review of an impurity. Now the US Food and Drug Administration is announcing a similar voluntary recall. Both recalls are due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, FDA says, not all products containing valsartan are being recalled...

Hypertension Drug Development: FDA Draft Guidance Outlines Recommendations

The US Food and Drug Administration (FDA) on Friday issued draft guidance providing recommendations for sponsors looking to develop drugs to treat hypertension in patients already taking several other antihypertensive medications. FDA says the guidance was developed in response to requests from drugmakers who sought input from the agency on treating resistant hypertension, or hypertension that is "not adequately controlled by maximally tolerated doses of three or more antihypertensive drugs with different mechanisms of action. "FDA encourages the development of additional classes of drugs for...

FDA approves the first drug with an indication for treatment of smallpox

The U.S. Food and Drug Administration today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox. Though the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that smallpox could be used as a bioweapon. “To address the risk of bioterrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that could be employed as weapons. Today’s approval provides an important milestone in these efforts. This new...

Europe -
Quality, preclinical and clinical aspects of gene therapy medicinal products

This guideline is a revision of the Note for Guidance on the Quality, Preclinical and Clinical aspects of gene transfer medicinal products (CPMP/BWP/3088/99), which was published in 2001. It defines scientific principles and provides guidance for the development and evaluation of Gene Therapy Medicinal Products (GTMPs) intended for use in humans and presented for Marketing Authorisation Application (MAA). Its focus is on the quality, safety and efficacy requirements of GTMPs. Adopted guideline

FDA Releases Draft ICH Guidance Revision on Elemental Impurities

The US Food and Drug Administration (FDA) on Thursday released draft guidance for industry that was prepared by the International Council for Harmonisation (ICH) on elemental impurities. The 7-page guidance, entitled “Q3D(R1) Elemental Impurities,” revises the existing ICH guidance for industry “Q3D Elemental Impurities” and provides an updated permitted daily exposure (PDE) for the cadmium inhalation route of exposure. “The updated PDE of 3 micrograms (µg)/day is based on a modifying factor approach like that used for calculating the PDEs for the cadmium oral and parenteral routes of...

Canada -
Health Canada Clarifies Policies for Notifications of Foreign Regulatory Actions

Health Canada issued new guidance on Thursday to aid pharmaceutical companies in complying with previously set requirements on notifications of foreign regulatory actions. The guidance operationalizes Health Canada’s interpretation of the notification requirements under provisions of the Protecting Canadians from Unsafe Drugs Act . “These provisions are intended to improve the collection and assessment of new relevant safety information in respect to any serious risk of injury to human health involving regulatory issues in foreign countries and help determine an appropriate response in Canada...



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