International – WHO/IAEA tackle investigational radiopharmaceutical GMP in draft guidance

The World Health Organization (WHO) and the International Atomic Energy Agency (IAEA) have released a draft guideline on good manufacturing practices for investigational radiopharmaceuticals.
The March 2021 document is the first working draft of a revision to the existing guidelines on good manufacturing practices (GMP) for investigational products. Consultation is open through the end of April 2021, with a revised document expected to be worked up for public consultation by July 2021.
The revisions are coming as the use of radiopharmaceuticals to diagnose and treat cancers and other diseases is expanding rapidly; this growth “is accompanied by a set of challenges due to the complexity and unique nature of these agents,” according to the draft.
« Having inadequate manufacturing controls during early clinical evaluations either carries the risks of unnecessary patient harm or jeopardizes the validity of the collected study results,” noted the authors of the draft guidance. However, they pointed out, overly burdensome or redundant controls may slow innovation in an area where lifesaving technologies are being developed…