Pharma GMP News of the Week: 17-July-2022

Period: July 10, 2022 to July 16, 2022

CDSCO, India has published three draft guidelines on performance evaluation, postmarket surveillance and stability studies to reshape the manufacturer’s approach for vitro diagnostics (IVDs)

Date of guidances: July 7, 2022

To read the guidance, click to the following links.

News from EMA “EMA launches pilot project on analysis of raw data from clinical trials”

Date of news: July 12, 2022

The purpose of this pilot project is to assess whether the analysis of ‘raw data’ from clinical trials by regulatory authorities enhances the evaluation of MAAs for post-authorisation applications as well as new medicines and to study the practical aspects of the data analysis and submission of data.

Source: https://www.ema.europa.eu/en/documents/other/information-about-raw-data-proof-concept-pilot-industry_en.pdf 

MDCG issued guidance on “Harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR)”

Date of news: July 13, 2022

Purpose of the guidance is to enable Member States and other relevant stakeholders to meet their obligations under the IVDR effectively simultaneously reducing any potential additional burden on the parties concerned. 

This will be helpful when the exchange of information would be difficult, the possibility is nil, to get based on the corresponding provisions of Directive 98/79/EC. 

Source:  https://health.ec.europa.eu/latest-updates/mdcg-2022-12-harmonised-administrative-practices-and-alternative-technical-solutions-until-eudamed-2022-07-13_en 

FDA has published final guidance on “Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format”

Date of news: July 15, 2022

The purpose of this guideline is to provide suggestions for developing the information and format of a patient Instructions for Use (IFU) document for human prescription drug and drug-led or biologic-led combination products as well as biological products submitted under NDA or BLA.

Source: https://www.fda.gov/media/128446/download 

European Union (EU) Commission issued its draft legislative proposal for a new EU Regulation on Blood, Tissues and Cells (BTC)

Date of news: July 15, 2022

The draft is an outcome of comprehensive revision of the current EU legislation that has included a huge consultation of international organizations active in the field and BTC stakeholders. 

The objective of the drat provides the foundation for a robust and future-proof legislative framework that will provide better protection for both recipients and donors of BTC and improve the existing long-standing cooperation between the EU and the Council of Europe/EDQM.

Source: https://www.edqm.eu/documents/52006/348324/Press+release+-+Council+of+Europe_EDQM+supports+draft+legislative+proposal+for+a+new+EU++Regulation+on+the+safety+and+quality+of+Blood%2C+Tissue+and+Cells+-+July+2022.pdf/9cdd9b7d-c088-9c71-a08a-25c2599a8c8a?t=1657874072597 

ICH published draft Guideline presentation of ICH M12 on its website

Date of news: July 15, 2022

This Step 2 info Presentation has been prepared by the M12 Expert Working Group post publishing draft Guideline on Drug Interaction Studies.

Source: https://database.ich.org/sites/default/files/ICH_M12_Step2_Presentation_2022_0714.pdf

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