Regulations of Innovator Biopharmaceuticals- Multi Country study.

      Аннотация: Biopharmaceutical innovation has had a profound health and economic impact globally. Developed countries have traditionally been the source of most innovations as well as the destination for the resulting economic and health benefits. The rapid pace of discovery in the biotechnological sciences has created substantial difficulties for the Federal food and Drug Administration (FDA), European Union and all major regulators, which ensures the safety and efficacy of biopharmaceutical products. The speed of biotechnological discovery necessarily requires rapid product approval by regulators, as any substantial regulatory delay in the introduction of new biological products could result in these products becoming obsolete before they ever reach the consumer market. This Book will highlight the regulatory aspects of innovator biopharmaceuticals in various countries.

Ключевые слова: Regulations, Biopharmaceuticals, biologics