GMP News - Regulatory Affairs

09.10.19

How to get GMP Certificates, Importation Licenses & Broker Registrations in UK?

The MHRA recently provided details for new licence applications and variations on the agency´s Inspectorate Blog - together with some helpful links.

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08.10.19

Evaluation of the Immunogenicity of Therapeutic Protein Products - FDA Scientists developed a new Tool

For the important assessment of possible immune responses to therapeutic protein drugs, FDA scientists developed a new mathematical tool to calculate the expected risk of producing antibodies against the biological drug.

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08.10.19

ATMP from Third Countries - New Q&A Paper on Batch Release published

With a new Q&A document, the EMA has provided information on the release of Adavanved Therapy Medicinal Products (ATMP)  imported into the EU by the Qualified Person without batch re-testing.

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26.09.19

EDQM updates two Guidelines on the CEP procedure

The updating of two important documents by the EDQM reflects the current practice of the CEP procedure. Read more about the competencies and responsibilities of the various bodies in the CEP application procedure and about the code of practice for assessors and inspectors.

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26.09.19

Official Danish Cannabis-Monograph

Denmark has published its official pharmacopoeial monograph for Cannabis: Cannabisblomst (Cannabis flos).

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18.09.19

New FDA guidance on Child-Resistant Packaging

The FDA published a new guidance on Child-Resistant Packaging (CRP). The guidance is intended to assist applicants, manufacturers, packagers, and distributors who include CRP statements in their drug product labeling.

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04.09.19

USP Packaging Standards

The USP´s General Chapters—Packaging and Distribution Expert Committee provided an overview of USP´s current packaging standards-strategy in the curent issue of Pharmacopeial Forum. The stimuli article covers USP general chapters related to the suitability for use for materials of construction including plastics and elastomers.

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07.08.19

FDA's promotion for cell and tissue products - the TRG Rapid Inquiry Program (TRIP)

With an additional program to support manufacturers of cells, tissues and cell-based products, the FDA is trying to accelerate its promotion of the development of regenerative therapies.

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31.07.19

Brexit: Industry should keep Timelines for Batch Testing Facilities

The EMA points out that - independent from the Brexit postponement - MAHs should use the remaining time to complete all necessary preparations.

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31.07.19

EMA publishes Draft on Quality Requirements for Combination Products

The European Medicines Agency (EMA) has published a draft guideline on quality requirements for combinations of medicinal products and medical devices (so-called Drug Device Combinations - DDCs). What does the draft contain?

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24.07.19

Recent Changes to the USP - What You Need to Know

The USP is currently introducing some changes to the format of the USP and to its online platforms. Amongst others the USP plans to discontinue printing the USP-NF in the current format.

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24.07.19

French pilot programme for medical cannabis

The objective of the French pilot programme is to follow the recommendations of the CSST to evaluate cannabis prescribing and dispensing, and to collect safety and efficacy data. However, medical cannabis is not expected to be legalized in France prior to the end of 2021.

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17.07.19

New Zealand proposes new legislation for medical cannabis

New Zealand released a proposed regulatory approach for medical cannabis. The implementation of the medical cannabis program is anticipated to start in the first quarter of 2020. In addition, the document proposes two options for GMP.

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10.07.19

Canada´s New Regulatory Approach for Cannabis Products

Health Canada proposes a regulatory pathway for a new class of cannabis products referred to as Cannabis Health Products that would not require practitioner oversight.

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09.07.19

FDA keeps an eye on use and marketing of cell and tissue products

The FDA publishes an Untitled Letter to a manufacturer of stem cell products that are used to treat various diseases and are not expected to meet regulatory requirements.

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