India Proposes Classifying Manipulated Cells And Tissue Products As Drugs
The Indian government is proposing to change the definition of a new drug to include substantially manipulated stem cell and tissue-based therapies.
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India’s Stem Cell Guidelines Mandate Additional Checks
Draft update to national guidelines factors in additional safeguards and makes it mandatory to establish institutional panels to review stem cell research. Gene editing would be an area of "restrictive" research.
WHO Consults On Updates To 24-Year-Old GMP Requirements For Pharma Excipients
The World Health Organization wants to update its guideline on manufacturing pharmaceutical excipients to ensure these products meet the requirements for quality and purity that they purport or are represented to possess.
European Commission Steps In To Address Drug Trial Delays Due To IVD Regulation
The commission is in talks with EU member states to identify possible regulatory bottlenecks in the approval of combined clinical trials for a medicinal product and a clinical performance study of an IVD.