Various Guideline On Human Cell-Based Medicinal Products On Being Followed

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Can you think of developing medicinal products from the human cell? Is there a possibility of creating a human with his cells and tissues? Today medical science is raising its bar every day. You would hear many new inventions and therapies are coming around to treat many diseases. The cells, tissues, and genes have set up a different field to treat many diseases. Cells, genes, and engineered tissues are considered as new active substances to develop new medicines. There are a number guidelines on human cell based medicinal products coming along.

New Opportunities For Treatment Of Diseases

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Advanced therapy medicinal products (ATMPs) include gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products that can offer the new opportunity to cure various diseases and injuries. Cell-based medicinal products, unlike cell and tissue transplants, undergo additional manipulation during production, resulting in substantial changes in the characteristics of the cells. They can also be used for a different function in the recipient than the original function in the donor. The design, development, and authorization of medicine are a long and complex process. Regulation needs to be applied from the early stages of developing new medicine to ensure that it meets quality, efficacy, and safety for administration in humans.

Regulatory Agencies To Setup Guideline On Human Cell-Based Medicinal Products

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The three most important regulatory agencies that regulate the development of a medicine for human use are the European Medicines Agency (EMA) in the European Union (EU), the Food and Drug Administration (FDA) in the USA, and the Ministry of Health, Labour and Welfare (MHLW) in Japan. Its main mission is to achieve management in the technical guidelines on the quality, safety, and efficacy of new medicines. This organization brings together regulatory authorities, the pharmaceutical industry, and scientific experts from the USA, Japan, and Europe. These agencies are working to find out the best way out for various diseases and problems.

Manufacturing Of Cell-Based Medicinal Products

Technical requirements for somatic cell therapy medical products are based primarily on quality, safety, and efficacy aspects. In contrast to traditional medicines, somatic cell therapy medicinal products have different and more specific characteristics. The risk analysis of the whole manufacturing process, the quality of manufacturing aspects, and nonclinical and clinical development should be considered when manufacturing somatic cell therapy medicinal products. All batches of an SCTP manufactured for the clinical phase should be carried out under GMP standards. The manufacturing process of an SCTP for clinical use must be consistent and reproducible, providing sufficient quality to the final product for patient safety.


Application, administration, or implantation of human cells is opening new avenues to search for the treatment of acute diseases, some of which are as yet incurable. In the last years, encouraging observations at the preclinical level have promoted the development of cell therapies in distinct clinical phases. There is the various guidelines on human cell-based medicinal products, followed by various regulatory agencies while producing these cell-based medicines. You will soon see a new revolution in medical science with new inventions and medicines.

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