GMP News - Regulatory Affairs


FDA´s new policy regarding grouping of supplements for CMC changes

The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) released a new document outlining how supplements can be grouped together and submitted concurrently for the same chemistry, manufacturing and controls (CMC) changes. Find out more about Policy and Procedures regarding the Review of Grouped Product Quality Supplements.



Minutes of the HMPC Meeting Published

On 2 February 2016, the EMA published the comprehensive minutes of the HMPC Meeting on 23-24 November 2015. Herein, you can find a lot of information about the work of the HMPC in the past year. Read more about the HMPC meeting last November.



Pharmacovigilance: GVP Updates and EMA Newsletter

The European Medicines Agency (EMA) has revised several modules and documents of the Guideline on good pharmacovigilance practices (GVP) and published them for comment, i.e. finalised a document. Read more about the GVP updates.



MHRA Pharmacovigilance Inspection Metrics Report Published

The MHRA GPvP inspectorate published their latest inspection metrics report for the period of April 2014 to March 2015. Read more about the findings identified during all 48 inspections conducted during this period.



FDA extends comments for "established conditions" guidance

The FDA extends the comment period for the CMC Guidance Document on "established conditions". Comments are now due January 4, 2016. Find out more about the "Established Conditions: Reportable Chemistry, Manufacturing, and Controls ("CMC") Changes for Approved Drug and Biologic Products; Draft Guidance for Industry."



ICH announces organisational changes

The international Conference on Harmonisation (ICH) changes its name to The International Council for Harmonisation (ICH) and reforms its organisational structure. Read more about ICH´s organisational changes.



What are "complex manufacturing processes"? A recent reply from the EMA

Sometimes a clear definition of terms is crucial in the communication between authorities and pharmaceutical companies. Find out what the European Medicines Agency EMA defines as "complex manufacturing steps" and what authorisation holders providing a variation application need to consider.



New HMPC Concept Papers published on Herbal Medicinal Products

Two new concept papers on the planned revision of the EMA/HMPC documents on the quality of herbal medicinal products and on the specifications of herbal medicinal products were published by HMPC on 1 June 2015. Please read on for further information on the HMPC Reflection Papers.



Updating of the HMPC-Guideline on the use of the CTD Format in the Registration of Traditional Herbal Medicinal Products

Use of the CTD format is mandatory for the registration of traditional herbal medicinal products. Now, the EMA wants to update the HMPC Guideline in this respect. In future, a mock-up will also be part of the Guideline. Read more about the Revision of the EMA/HMPC Guideline.



New EMA Guideline on the Manufacture of the finished Dosage Form

A new draft Guideline on Manufacture of the finished Dosage Form has been published to provide clarification for the CTD Module 3 of the marketing authorisation dossier.



HPMC Reflection Paper on Microbiological Aspects of Herbal Medicinal Products Finalised

The EMA/HMPC Reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products has been published in its final version. Find further information on the EMA/HMPC Reflection Paper.



HMPC Document on the systematic Review of Monographs Herbal Medicinal Products updated

For the systematic review of the topicality of monographs and list entries the HMPC has updated a procedure which is supposed to ensure that this information is reviewed every 5 years. Find out more about the EMA/HMPC Document for systematic Review.



FDA finalizes Guidance on Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products

The FDA finalized the Guidance on "Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products". Read more about the new FDA Guidance.



CMDh Position Paper on QR Codes Published

According to a position paper of the CMDh, package leaflets and outer packaging of medicinal products can be tagged with QR codes in the future. This will apply to both prescription and over-the-counter medicinal products.  Read more here in the News.



Final Concept Paper ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle

Currently there are no harmonised approaches to technical and regulatory considerations for the lifecycle management of pharmaceutical products. Therefore, ICH has just published a Final Concept Paper for a new ICH Q12 Guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle. The proposed ICH Guideline is intended to fill this gap. Please find more information in our GMP News.


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