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ABSTRACTIntroductionA new category of products, i.e. regenerative medicine products (RPs), has been defined for advanced therapies medicinal products in Japan, as well as a legislative and regulatory framework to promote their clinical development.Areas coveredThis review analyses the most relevant features of the regulatory strategies and clinical development that led RPs to their approval in Japan.Expert opinionAs of 31stSeptember 2021, a total of 14 RPs were approved for 16 indications. From a regulatory standpoint, the available designations allow attractive benefit packages that promote the development of innovative products in Japan and is one of the key points to consider when the global regulatory strategy for the product is being developed. RPs regulations in Japan allow adaptive licensing and constitute shortcut through the clinical development to the approval. RPs have been mainly approved so far based on small studies with inconclusive and limited evidence of efficacy and safety, prioritizing the unmet medical needs of the target diseases, and therefore, the early access for patients. This review also compares the regulatory and clinical development for the current approved RPs in Japan with the development trends in the European Union and United States of America.

Background: Trigeminal neuralgia is a chronic disease characterized by intense facial pain that is caused by trigeminal nerve affectation. It usually affects adults from 50 years of age, and is more frequent in women. Additionally, it presents serious psychological effects that often lead to depression, which is why it is considered highly disabling. The therapeutic approach is based on the modification of nerve activity through electrical, surgical or chemical stimulation in specific regions of the nervous system. Objective: To perform a meta-analysis of the scientific literature related to invasive and non-invasive electrical neuromodulation of trigeminal neuralgia, in order to assess their effects over pain and adverse effects. Methods: A literature search was conducted in 4 databases, followed by a manual search of articles on invasive or non-invasive electrical neuromodulation to control the pain of trigeminal neuralgia, including the last 15 years. Results: Regarding non-invasive methods, clinical trials did not present enough results in order to perform a meta-analysis. Regarding invasive methods, clinical trials meta-analysis showed no statistical differences between different treatment methods. In all cases, improvements in patients' pain were reported, although results regarding adverse effects were variable. Conclusion: In the treatment of trigeminal neuralgia, the continuous radiofrequency provides better short and medium-term results, but pulsed radiofrequency shows less adverse effects after treatment, and has better results in the long-term.