GMP News Drug Safety/Pharmacovigilance

19.12.23

CTR / CTIS Guidance Update

The EMA and the HMA published revised guidance documents relating to the CTIS transparency rules and the transition of clinical trials. Amongst others, the concept of consolidated protocols has been clarified by providing an example illustrating the transition of a CTD trial to the CTR with different protocol versions approved in the Member States Concerned.

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19.12.23

Medical Cannabis - FDA's Perspective on Research and Drug Development

In addition to the recently published FDA guideline on Quality Considerations for Clinical Research with Cannabis the FDA now published an article to assist researchers with developing cannabis-derived product (CCDP) clinical research programs.

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19.12.23

FDA issues final Guidance on Benefit-Risk Assessment

The U.S. Food and Drug Administration (FDA) published the final guidance on Benefit-Risk Assessment. According to the agency, the intent of the guidance is to clarify how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions.

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07.12.23

First Electronic Product Information (ePI) for Human Medicines

The EMA recently announced that the Heads of Medicines Agencies (HMA), the European Commission (EC) and the EMA have published for the first time electronic product information (ePI) for selected human medicines harmonized across the European Union (EU). Does this mean the end of the printed package leaflet?

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07.12.23

Falsification of Ozempic Confirmed

Following the recent concerns that falsified batches of Ozempic® may have entered the market, the Official Medicines Control Laboratory (OMCL) Chemisches und Veterinäruntersuchungsamt (CVUA, Karlsruhe, Germany)  has determined that suspected batches of Ozempic® pre-filled pens contained insulin glulisine instead of the claimed active substance, semaglutide.

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07.12.23

Clinical Trials Regulation - Version 6.6 of the Q&As

The European Commission (EC) published an updated Version 6.6 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation (CTR). Amongst others, a new question on radiopharmaceuticals has been added.

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07.12.23

FDA issues draft Guidance on Confirmatory Evidence of Clinical Trials

The Confirmatory Evidence guidance supplements and expands the recommendations in the 2019 Substantial Evidence of Effectiveness draft guidance by providing further detail on the use of data drawn from one or more sources (e.g., clinical data, mechanistic data, real-world data).

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28.11.23

New Version of Quick Guide for Sponsors

The European Commission has published a new Version 3 of the Quick Guide for Sponsors. The revised guide provides clarifications on the submission of the IMPD-Q (Investigational Medicinal Product Dossier - Quality) for the IMP manufacture.

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28.11.23

EMA launches Website for accelerating EU Clinical Trials

The EMA has launched a dedicated website for the Accelerating clinical trials in the European Union (ACT EU) initiative.

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28.11.23

EMA releases Youtube Videos of Workshop on Real World Data

The European Medicines Agency (EMA) held a workshop in June on the quality of Real World Data (RWD) and its use to demonstrate Real World Evidence (RWE). In the meantime, Youtube video recordings of both days have been published.

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26.10.23

Quality Attributes for Ophthalmic Drug Products

The FDA published a draft guidance that discusses quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye.

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26.10.23

EMA Publishes revised CTIS Transparency Rules

The EMA has endorsed the revised transparency rules for the EU Clinical Trials Information System (CTIS). According to the agency, the simplifications introduced will give access to clinical trial information to stakeholders, patients and healthcare professionals in a faster and more efficient way.

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26.10.23

Key Factors for Compassionate Use

The FDA published a draft guidance for institutional review boards (IRBs) and clinical investigators regarding the key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions (IPEAS).

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26.10.23

FDA's final Guidance on Real-World Data and Real World Evidence

The U.S. Food and Drug Administration (FDA) issued the final guidance for the Use of Real-World Data (RWD) and Real-World Evidence (RWE) to support regulatory decision-making for drugs and biological products. What are the sponsor's responsibilities?

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25.10.23

FDA Publishes Structured Product Labeling Guide for Cosmetic Products

The U.S. Food and Drug Administration has published an updated structured product labeling (SPL) implementation guide with validation procedures for cosmetic product facility registrations and product listings.

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