The use of stem cells as medicines is a promising and upcoming area of research as they may be able to help the body to regenerate damaged or lost tissue in a host of diseases like Parkinson′s, multiple sclerosis, heart disease, liver disease, spinal cord damage, cancer and many more. Translating basic stem cell research into routine therapies is a complex multi-step process which entails the challenge related to managing the expected therapeutic benefits with the potential risks while complying with the existing regulations and guidelines. While in the United States (US) and European Union (EU) regulations are in place, in India, we do not have a well-defined regulatory framework for “stem cell based products (SCBP)”. There are several areas that need to be addressed as it is quite different from that of pharmaceuticals. These range from establishing batch consistency, product stability to product safety and efficacy through pre-clinical, clinical studies and marketing authorization. This review summarizes the existing regulations/guidelines in US, EU, India, and the associated challenges in developing SCBP with emphasis on clinical aspects.

Medical Device (MD) is one of the fastest growing sector and so are the associated regulations. From lack of even policies and guidelines to stringent MD legislations in others, the requirements vary across countries. Understanding and interpreting the global MD evolving regulations and requirements is important (for not just the manufacturers, importers, wholesalers and distributors but even the clinicians) in the current global competitive market. This review is an attempt to do that by giving an overview of the prevailing MD regulations in United States (U.S), Europe and India.

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A clinical trial registry (CTR) is an official platform for registering a clinical trial (CT) with an objective of providing increased transparency and access to CTs to the public at large. Clinical Trials Registry - India (CTRI) is a free online public record system for registration of CTs being conducted in India. The vision of the CTRI is to ensure that every CT conducted in the region is prospectively registered with full disclosure of the trial data set items. With more number of CTs being conducted in the country, with a large number being global multicentre trials, it is binding on the industry/investigators/sponsor to comply with the requirements laid down. While there are pros and cons, there is enough scope for improvement of CTRI.

Monoclonal antibodies (mAbs) were initially used as laboratory reagents, later they were adopted as clinical diagnostic reagents, and eventually as therapeutic agents. The develop-ment of therapeutic mAbs commenced in the early 1980s and by 1986 the first mAb for human use “Orthoclone OKT3®” was approved by the US Food and Drug Administration (FDA). The next wave of antibody products were mostly anticancer agents which were approved in the US and Europe in the 1990s. The technological evolution from murine-based therapeutic mAbs to chimeric (part murine part human protein), humanized, and fully human antibodies has led to a reduction in immune-mediated clearance and hypersensitivity, improved the safety and feasibility of repeated administration making them therapeuti-cally viable.Since the commercialization of the first therapeutic mAb, these products have become a dominant component of the biopharmaceutical marketgenerating revenues of several billion dollars.The area of biosimilar antibody development is positioned for substantial growth with regulatory agencies like the European Medicines Agency (EMA) coming up with new guidelines on similar biological medicinal products followed by Health Canada, the US FDA and others, addressing biosimilar product development. With few of the blockbuster mAbs going off-patent in the next decade, companies with expertise in manufacturing biosimilar mAbs with the right kind of business and regulatory strategy are likely to have good value proposition.