News

A further Step for the SoHO Regulation

At the end of May, the EU member states adopted the new SoHO Directive, meaning that transposition and implementation of the regulations on substances of human origin (SoHO) are continuing. Find out what the regulation contains and what the next steps are.

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Update of Guideline on Epidemiological Data

The European Medicines Agency (EMA) has released a concept paper on the revision of the guideline on epidemiological data on blood transmissible infections for public consultation.

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Final Approval of SoHO Regulation

On 24 April 2024, the EU Commission finally approved the regulation “Quality and safety standards for substances of human origin for human use”.

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FDA Warning Letter to a Biotechnology Company in China

During an investigation by the FDA, several CGMP violations were identified, which may lead to the denial of importation of drug products into the United States.

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HTS/NGS - Draft Ph.Eur. Chapter "High-Throughput Sequencing for detecting Viral Extraneous Agents"

In Pharma Europe, the publication of a draft of the new chapter "2.6.41 High-throughput sequencing for the detection of viral extraneous agents" represents a step forward in two important areas. Firstly, with regard to the viral safety of medicinal products and secondly, with regard to the regulatory establishment of modern detection methods.

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FDA Warning Letter on misbranded and unapproved Drugs

Due to ignorance of the FDA definition of drugs, a US pharmaceutical company has received a Warning Letter regarding their products.

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New Regulation on Blood, Blood Products and Plasma

News on the Regulation on standards of quality and safety of substances of human origin (SoHO). The regulation are intended to help ensure that the donation and processing of blood, blood products and plasma reflect the latest legal, political and scientific standards.

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EMA and FDA publish Q&A Document on their accelerated Approval Programmes

In December, the EMA and U.S. FDA published a joint Q&A document on accelerated approval of important innovative medicines and therapies entitled: "EMA-FDA joint Q&As on Quality and GMP aspects of PRIME/Breakthrough therapy applications".

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FDA Draft Guidance on Potency Assays for Cellular and Gene Therapy Products

At the end of December, the FDA published a new draft guidance document on potency assays for Cell and Gentherapeutics. In addition to recommendations for potency testing, this guidance is also intended to help with the overall strategy for ensuring potency.

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EDQM's new Reference Substance for Hepatitis C Virus

Following the successful completion of the Biological Standardisation Programme study to establish Hepatitis C Virus (HCV) Biological Reference Preparation (BRP) batch 2 for nucleic acid amplification techniques (NAT), the result has been published in the online journal Pharmeuropa Bio & Scientific Notes: "Establishment of Ph. Eur. Hepatitis C Virus RNA for NAT assays BRP batch 2".

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