GMP News - Pharmaceutical Development / Clinical Trials / GCP

The ICH E19 Concept Paper and Business Plan have been released. Read more about the E19 Concept Paper on Optimization of Safety Data Collection.

Recently, the revised Ph. Eur. Monograph Tablets (0478) has been published in Ph. Eur. Supplement 9.3. Read more about the revised monograph on the dosage form Tablets.

A new USP general Chapter that describes the basic principles and practices used in the characterization of tablet compression has been approved and published. Read more about the new USP chapter <1062> Tablet Compression Characterization.

The revised general chapter <771> Ophthalmic Products-Quality Tests has been published. Read more about USP chapter <771> describing quality tests for opthalmic dosage forms.

On 12 April the European Medicines Agency (EMA) has released a draft guideline on good clinical practice (GCP) compliance in relation to Trial Master Files (TMF) for public consultation. The guideline is part of the work related to the implementation of the new Clinical Trial Regulation (EU) 536/2014. It also contains the revised version of the reflection paper on TMF, considering comments collected during public consultation. Read more about the Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials.

The EMA recommends the suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs. Medicines where suitable alternative data are available can remain on market. Read more about the press release regarding medicines recommended for suspension.

The USP is requesting early input from stakeholders on two new proposed General Chapters regarding the characterization of viscoelastic properties of semisolids. Read more about the proposed chapters <915> Measurement of Structural Strength of Semisolds by Penetromety and <1912> Measurement of Hardness of Semisolids.