The Turkish Medicines and Medical Devices Agency (TITCK) has published a new revision of its guidelines related to inspections regarding the storage and distribution of medicinal products for human use.
The FDA has updated one of its internal manuals to add a risk factor for facilities in countries where there has been an increase in violations. This is nothing more than a risk factor for a region or an entire country.
Colored glass containers are usually used to contain light-sensitive drug products. A previously issued USP Stimuli Article on the measurement of the protective properties of colored glass containers has now been republished. The article provides proposed maximum allowed specific transmission values for colored glass containers.
Because the application of mRNA technology is relatively new, regulatory guidelines and industry standards to govern non-compatible aspects of mRNA quality during development and manufacturing are still evolving. The USP has now defined standards and is seeking input during the comment period on a new draft guidance version for the analysis of mRNA.
The complexity of therapeutic protein-based medicinal products makes characterisation of these products difficult. However, the use of artificial intelligence and machine learning in flow imaging microscopy opens up new possibilities.
The FDA recommends and provides guidance on potency assays for monoclonal antibodies and other therapeutic proteins that directly target viral proteins or host cell proteins that mediate pathogenic mechanisms of infection. The purpose of this FDA guidance is to assist in the development and implementation of such assays to ensure adequate information on efficacy throughout the shelf life of the product.
The pharmaceutical industry's adoption of Quality Culture is transforming the way organisations approach quality management. Although challenges exist in fostering a culture of quality, the benefits outweigh the obstacles.
Due to numerous GMP deficiencies, a US company in the field of solid dosage form packaging received a Warning Letter from the FDA. The inspection had already taken place in November 2022. Since the FDA found the company's response to the Form 483 as insufficient, the Warning Letter now followed.
The EMA has updated its ICH M11 website to include overviews of comments received on the M11 draft documents. In particular, a huge number of comments were received from organizations relating to the ICH M11 template.
Following the previously published public consultation document on Data Protection of Information uploaded in the CTIS, the EMA has now published an interim guidance. The document is available for CTIS users and provides guidance on the protection of personal data and commercially confidential information (CCI) while using CTIS.
The FDA has received an increasing number of questions regarding the extent to which generally accepted scientific knowledge (GASK) may be relied on for drug or biological product approval. Therefore, the agency published a draft guidance which describes instances in which it may be appropriate to rely on GASK to meet certain nonclinical safety requirements for new drug applications.
The FDA published a draft guidance on decentralized clinical trials (DCTs). Examples of decentralized elements include obtaining laboratory tests at a local facility rather than a research medical center or conducting a clinical follow-up visit in the trial participant's home.
The European Medicines Agency had launched a public consultation on the revision of the transparency rules of the Clinical Trials Information System (CTIS). Stakeholders were invited to send their comments via an online form by end of June 2023.
One of the most important documents in the context of medical device regulation is the technical documentation. Updated as version 2, a helpful position paper from the Team Notified Body provides assistance in this regard as a best practice guide.
The topic of artificial intelligence/machine learning (AI/ML) is currently all around. The FDA has also taken up AI/ML and published various draft guidance documents. A current draft is aimed at manufacturers of medical devices that contain software.
An EU Regulation laying down specific rules for medicinal products for human use for Northern Ireland has been published in the Official Journal of the EU. It mainly concerns importation into NI and safety features.
In June, the VDI published the new guideline 6022 Blatt 1.1 as a draft for comment. The new document is intended to expand on the existing Guideline 6022 Blatt 1, which describes the overall hygiene assessment of ventilation and air-conditioning systems.
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.
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.
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.
More than 60 participants attended the ECA Webinar "GDP Update 2023" in March. Many interesting aspects were discussed in the Q&A session. In total, about 20 questions were addressed to the speaker, Dr. Christian Grote-Westrick, which he answered in writing afterwards. We have compiled a selection of the questions and answers for you. You can read Part 3 here.