Abstract
The recent excellent EMAS Consensus Statement [ [1] Lambrinoudaki et al. Menopause, wellbeing, and health: a care pathway from the European menopause and andropause society. Maturitas. 2022; 163: 1-14 Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar ] clearly describes how menopausal hormone treatment is not a single entity; that is, different preparations with different characteristics and indications are available, suitable for different indications and preferences. Type, dose, and route of administration make the difference. This important concept has now been confirmed by a regulatory agency. For the very first time in Europe, a product listed among the notorious hormone replacement therapy (HRT) options is going to be available over the counter. The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has reviewed all the efficacy and safety evidence, and, with the collaboration of the British Menopause Society and the Royal College of Obstetricians and Gynaecologists, has announced that it has reclassified Gina 10 μg tablets (estradiol hemihydrate) from a prescription-only medicine to a pharmacy medicine. The change is due to come into effect in September 2022 [ [2] https://www.gov.uk/government/news/easier-access-to-locally-applied-hrt-to-treat-postmenopausal-vaginal-symptoms-in-landmark-mhra-reclassification Google Scholar ]. This is an epochal change. Low-dose vaginal estrogens have been widely used since the 1980s and are considered effective and safe for millions of women with severe symptoms that negatively impact their everyday life. Thus, an important national agency acknowledges that not all HRT products are the same. For the time being, this change concerns just one product, but, obviously, we are waiting for a similar revision for other low-dose local products containing either estriol, promestriene, or prasterone.
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