GMP News - Pharmaceutical Development / Clinical Trials / GCP

14.02.19

Radiopharmaceuticals - Draft Guideline on non-clinical Requirements

In response to the increasing need for a guidance paper for radiopharmaceuticals in non-clinical settings, the EMA has published a "Draft guideline on the non-clinical requirements for radiopharmaceuticals".

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14.02.19

FDA Guideline on Immunogenicity Testing of Therapeutic Protein Products published

In January, the FDA published a guide on immune responses to protein products: "Immunogenicity testing of therapeutic protein products - Development and validation of assays for the detection of antidrug antibodies".

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14.02.19

ICH´s Approach for Harmonization of Standards for Generic Drugs

The International Council for Harmonization (ICH) recently published a new reflection paper on "Further Opportunities for Harmonization of Standards for Generic Drugs".

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30.01.19

EMA publishes comments on ICH Q12

The EMA recently released comments gathered during its public consultation for the ICH Q12 draft guideline. Read more about EMA ´s overview of comments received on ICH Q12 on pharmaceutical product lifecycle management.

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30.01.19

Counterfeit Protection: 13th Version of Questions & Answers Paper published

The European Commission has published version 13 of  the Questions & Answers document regarding the implementation of the rule on safety features for medicinal products for human use.

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24.01.19

EMA Guideline on Content, Management and Archiving of the TMF

The EMA published a new guideline on the content, management and archiving of the TMF clinical trial master file (paper and/or electronic).

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24.01.19

When does one speak of a "true" First in Human trial?

A new post, "Is it really a First in Human trial? Categorizing and assessing the risks correctly" has just been published on the MHRA Inspectorate blog.

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24.01.19

Clinical Trials if there is no Brexit Deal

To face the possibility of a Hard Brexit, the MHRA has issued updated guidance proposing some necessary arrangements in regard of Clinical Trials of IMPs.

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19.12.18

British Regulatory Authority MHRA criticises Cross Contamination Issue

The publication of EMA's "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities" and the related Q&A documents have given the topic cross contamination a greater importance.

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19.12.18

New Ph. Eur Monograph on PAT adopted

The European Pharmacopoeia (Ph. Eur.) Commission adopted 16 new texts including the general chapter on PAT - Process analytical technology (5.25).

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18.12.18

Gene Therapeutics - FDA updates Requirements for CMC Information

In recent months, the FDA has published a number of documents on gene therapy. With a draft guideline on "Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)", the next step in the update of the relevant guidelines has been taken.

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06.12.18

New ICH Topic M11 CeSHarP

A new ICH topic was endorsed by the ICH Management Committee in November 2018. Read more about the proposed new ICH M11 guideline Clinical electronic Structured Harmonized Protocol (CeSHarP).

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06.12.18

FDA allows greater flexibility for clinical investigators about informed consent

The FDA proposes to allow greater flexibility for clinical investigators about informed consent in minimal risk situations. Read more about Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.

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06.12.18

Dose Escalation - is it GCP compliant?

On the MHRA Inspectorate blog a new post has just been published emphasizing that according to GCP dose escalation practices should be the same regardless of whether a clinical trial involves healthy volunteers or patients. Read more about "Dose Escalation - is it GCP compliant?"

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03.12.18

New ICH Topic Q14 and Revision of Q2

A new ICH topic was endorsed by the ICH Management Committee in November 2018. Read more about the proposed new ICH Q14 guideline Analytical Procedure Development and the revision of Q2(R1) Analytical Validation.

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