Search Results for Excipients

Showing 1 – 9

EMA Adds New Excipients to Labeling Requirements By Michael Mezher - Published 09 October 2017

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.

Categories: News, EC, EMA, Drugs, Labeling

Tags: Excipients, Labeling, Package Leaflet

EC Unveils Revised Guideline on Pharmaceutical Excipients By Zachary Brennan - Published 28 February 2017

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. 

Categories: News, US, EC, EMA, Compliance, Drugs, Quality

Tags: excipients, excipient guideline, European Commission guidance

European Regulatory Roundup: GPs Create Expert Group to Liaise With EMA (5 May 2016) By Nick Paul Taylor - Published 05 May 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Compliance, Drugs

Tags: European Regulatory Roundup, ACS, excipients, CHMP

EMA Clarifies How to Include API Mix Data in a Marketing Application By Michael Mezher - Published 21 April 2016

The European Medicines Agency's (EMA) has released a new questions and answers document intended to guide sponsors on which procedures to follow when submitting a marketing authorization application for a drug containing an API mix.

Categories: News, Europe, EMA, Active pharmaceutical ingredients, Drugs, Manufacturing, Submission and registration

Tags: API mix, Excipients

French Regulators Find Cargill Manufacturing Site Non-Compliant With GMPs By Zachary Brennan - Published 02 November 2015

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.

Categories: News, Europe, EMA, Active pharmaceutical ingredients, Drugs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: ANSM, Cargill, excipients, alginic acid, Topaal, France drug manufacturing

China: SFDA Issues New Draft Excipient Rules By Ansis Helmanis, RegLink - Published 11 June 2012

Categories: Regulatory Update, China

Tags: Suppliers, Excipients, Supply Chain, State Food and Drug Administration, SFDA, regulation

China: New Draft Rules On Excipients By Louise Zornoza, RegLink - Published 05 June 2012

Categories: Regulatory Update, China, Quality

Tags: Excipients, SFDA, pharmaceutical, cGMP, drug

Brazil: New Quality Standards for Excipients By Ansis Helmanis, RegLink - Published 04 June 2012

Categories: Regulatory Update, Anvisa

Tags: Excipients, pharmaceutical, brazil, drug

EMA Releases Concept Paper on Excipient Labeling By Alexander Gaffney - Published 08 March 2012

Categories: EMA

Tags: Pregnant, Excipients, Concept Paper, Pediatric, Latest News