This third issue of GaBI Journal is the last of the volume for this year and marks the end of the first year of me taking up the Editor-in-Chief position for the journal. We have seen a very considerable variety of papers submitted and published during 2024.
The first Review Article in this issue by Dr Shivani Mittra et al. is titled ‘Aligning environmental, social, and governance to clinical development: moving towards more sustainable clinical trials’. These authors point out that drug development is among the highest producers of greenhouse gas emissions with clinical trials being the main culprit. They consider that there is an urgent requirement to develop tools capable of measuring the carbon footprint of clinical trials and guidelines on how to reduce it. The comprehensive article discusses how regulators, pharmaceutical companies, and clinical researchers can align with the environmental, social, and governance goals for the efficient conduct of clinical trials, including those for biologicals and biosimilars.
The issue continues with the second Review Article of international initiatives on pharmaceutical regulatory reliance and recognition by Mr Vimal Sachdeva of the World Heath Organization (WHO). This brightly illustrated contribution emphasises the pressure on organizations like WHO to facilitate timely access to safe, effective, and good-quality health products worldwide. It highlights the need to harmonize regulatory decisions and expedite the regulatory approval process.
This is followed by a Perspective by Drs Joseph P Park and Gillian R Woollett titled ‘US interchangeability designation: are we ready to cut the Gordian knot?’ It discusses how the US Food and Drug Administration’s current thinking on interchangeability has evolved since the legal designation was first created some time ago and strongly supports the improvements implemented. This is a continuation of publications by these authors on this and similar issues.
The next article is a Perspective titled ‘The challenge for drug shortage: lessons learned from the quality issues of Japanese generic drug companies’ from Dr Takanao Hashimoto et al. This examines the repercussions of recent quality and regulatory crises in Japan’s generic pharmaceutical sector, focusing on incidents involving Sawai Group Holdings and other manufacturers. It calls for strategic reforms to reconcile cost containment with quality and supply chain stability, ensuring the pharmaceutical industry can meet both domestic and international healthcare demands effectively.
The final item in this issue is a sponsor-funded editorial summarizing an interview on ‘Transforming healthcare: CinnaGen’s leadership in follow-on biologicals/biosimilars development and market expansion’ with Dr Haleh Hamedifar who is the Chairperson of CinnaGen. CinnaGen is the largest Iranian biopharmaceutical company and the biggest such company in the Middle East and North Africa (MENA) region. Its commitment to affordable, accessible health care through the development of high-quality follow-on products is transforming patient care, particularly in underserved regions like MENA.
I wish all readers and contributors of GaBI Journal the very best for 2025.
Robin Thorpe, PhD., FRCPath
Editor-in-Chief, GaBIJournal
Disclosure of Conflict of Interest Statement is available upon request.
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