GMP News - APIs and Excipients

20.07.23

Ph. Eur. Update on Pharmaceutical Preparations

A revised version of the Ph. Eur. general monograph Pharmaceutical Preparations has been published. In particular a reference to the general Ph. Eur. chapter Contaminant pyrrolizidine alkaloids (2.8.26) has been added.

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19.07.23

FDA Warning Letter issued due to no response

In June 2023, the U.S. FDA issued a Warning Letter to the Chinese company "Chengdu KeCheng Fine Chemicals Co., Ltd.". According to the Warning Letter, the company is registered within the USA as an API manufacturing facility, which shipped APIs to the U.S. several times.

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19.07.23

EMA publishes new and updated product-specific Bioequivalence Guidance

The European Medicines Agency (EMA) has published new or updated product-specific guidelines for the demonstration of bioequivalence.

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27.06.23

EMA Update on GACP Revision

The European Medicines Agency (EMA) has published on its website the detailed minutes of the Herbal Medicinal Products Committee (HMPC) meeting from 13-15 March 2023. In the meeting, the HMPC discussed some issues known to cause difficulties in procedures and ideally to be addressed during the current GACP revision.

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27.06.23

Updated Public Statement of the HMPC on HMPs containing Estragole

In 2005, the HMPC prepared the "Public statement on the use of herbal medicinal products containing estragole". Now, several footnotes were added in Table 1 of the document regarding the provided examples of estragole-containing plants.

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27.06.23

New Edition of the Herbal Guide

The EDQM has published a new edition of the Guide for the elaboration of monographs on herbal drugs and herbal drug preparations. The Guide provides general guidance on the structure of Ph. Eur. monographs of herbal drugs and herbal drug preparations and on the information to be included in them. In addition, principles for the preparation and revision of herbal monographs are explained.

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27.06.23

Cannabis Reference Standards DAB

The amended German Pharmacopoeia (Deutsches Arzneibuch, DAB) is valid from 1 August 2023. The DAB 2023 now includes several revised texts for Cannabis reagents.

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21.06.23

Korean MFSD publishes Revision 7 of Comparative Dissolution Test Guideline

The Korean Ministry of Food and Drug Safety (MFDS) has revised the "Guidelines for Comparative Dissolution Test". A new version dated 18 May 2023 was published.

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07.06.23

Updates to the EMA Q&A Documents on Centralised Procedures

In April 2023, the Questions & Answers documents related to centralised marketing authorisation procedures were revised and published on the European Medicines Agency (EMA) website. The Q&As, which can be used by marketing authorisation holders and applicants of centralised procedures, provide answers to potential questions at different stages of the centralised marketing authorisation application process.

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31.05.23

FDA Form 483 due to Insufficient Investigations after OOS and OOT Results

The U.S. Food and Drug Administration (FDA) has published a Form 483. During an inspection at an Indian drug manufacturing side, several CGMP violations were documented. These concerns, among others, Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, where results were invalidated by retesting the batches without a scientifically justified root cause.

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31.05.23

Registration of APIs in Brazil - Q&As

In March 2023, the ECA offered the Live Online Training "How to register APIs in Brazil". With regard to Brazil's Registration procedures for APIs, a set of the most important questions raised during the training and the respective answers provided by the speakers Ms Marieke van Dalen, Global Regulatory Specialist, Aspen, The Netherlands, and Ms Susan Swiggers, Customer & Regulatory Support Officer, Aspen, The Netherlands, are listed in the following.

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24.05.23

APIC: ICH M7 "How to Do" Document published

The first version of the "Sharing Drug Substance M7 information to HA and MAH: "How to do" document -Interpretation of the ICH M7 guideline and other relevant guidelines with regard to M7 data sharing" and the associated templates were finalised in March and April 2023 and are now available on the APIC website.

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17.05.23

Medical Cannabis in Germany: From the BtMG to the Cannabis Act?

According to a draft version for the German Cannabis Law (Cannabisgesetz, CannG), cannabis for medical purposes will no longer fall within the scope of the Narcotics Law (Betäubungsmittelgesetz, BtMG). What changes may result?

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17.05.23

Draft of USP Chapter <711> Dissolution (PDG harmonized document) Published for Comments

In the Pharmacopeial Forum, PF 49(3), a proposal of a revised USP General Chapter <711> Dissolution has been published for comments. The background to the publication is the efforts of international harmonization of monographs and general analytical methods of the European, Japanese, and United States pharmacopeias. The new draft represents the Pharmacopeial Discussion Group (PDG) harmonized document.

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16.05.23

USP Publishes Draft on Quality Requirements for Cannabis

The USP previously announced to elaborate a chapter on quality considerations for Cannabis. Now the draft chapter <1568> Quality Considerations for Cannabis and Cannabis-Derived Products for Clinical Research has been published in PF 49.3. Comments can be sent to the USP until end of July.

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