News
RAPS: New FDA Warning Letters Highlight CGMP Deviations at API Plants in China, India
23.03.2017
The US Food and Drug Administration (FDA) on Tuesday released two new warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis
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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on the initiation of the review on conducting research by the company Micro Therapeutic Research Labs in India
05.01.2017
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on the initiation of the review on
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GMP: EMA issues new Guideline on "Chemistry of Active Substances"
05.01.2017
A medicinal product authorization application requires comprehensive information on origin and quality of an active substance. What information is required was defined in two Guidelines so far:
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RAPS: WHO Seeks API Manufacturers for Prequalification Program
25.10.2016
The World Health Organization (WHO) has released an invitation to active pharmaceutical ingredient (API) manufacturers as part of an effort to increase access to and the affordability of care and
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GMP: GDUFA: FDA's new Guidance on Self-Identification of Generic Drug Manufacturers
25.10.2016
The GDUFA (Generic Drug User Fee Amendments) is a legislative package which came into force in 2012 and entitles the US-American FDA to collect fees from generic drug manufacturers, who
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FDA: Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
20.10.2016
This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing
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EMA: Concept paper on good manufacturing practice and marketing authorisation holders
20.10.2016
The current EU Guide to GMP refers in several places to Marketing Authorisation Holder (MAH) companies and their responsibilities in relation to GMP ensuring that the manufacturing authorisation
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GMP: FDA issues new Draft Guidance on Elemental Impurities
20.07.2016
The ICH Q3D \"Guideline for Elemental Impurities\" was issued in December 2014 and recommended for adoption in the regulations portfolio of the ICH regions Europe, USA and Japan according to the
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FDA: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information
30.06.2016
This guidance focuses on the chemistry, manufacturing, and control (CMC) information that you should submit in an IND for an LBP. This guidance is applicable to all INDs of LBPs, whether clinical
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FDA: Elemental Impurities in Drug Products Guidance for Industry
30.06.2016
This draft guidance provides recommendations regarding the control of elemental impurities of human drug products marketed in the United States consistent with implementation of International
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