Market access – is always a challenge, especially for manufactures aiming to enter world’s major markets, such as the European Union and the United States.
Despite the harmonization of requirements for development of medicinal products, there may still be many differences, particularly for original, biological or ATMP products.
Competent authorities strive to provide support manufacturers and one of the ways to provide that support is by a scientific advice procedure. This procedure allows manufacturers to receive advice on development questions, which in turn reduces the amount of time and resources for bringing a product to market.
Since 2021 EMA and US FDA initiated a parallel scientific advice procedure, allowing manufacturers to get advice from both agencies simultaneously. According to General principles, the best candidates for PSA include important medicinal products, especially those being developed for indications lacking development guidelines, or if guidelines do exist, those for which EMA’s and FDA’s guidelines differ significantly. In addition, biosimilars, products with significant clinical safety, animal toxicology, or unique manufacturing concerns that could impede further product development are appropriate PSA candidates.
Feel the need for this kind of advice? STARoDuB team can provide you with our experience and full support in this process. Please reach us via our Contact form.
