The development of safe and effective pediatric medication is essential for ensuring that all children have access to the best possible medical care. However, pediatric drug development is a complex and challenging field, and there are several factors that have hindered progress in this area in Japan.

In recent years, there have been a few positive developments, which carry the potential to improve the future of pediatric drug development in Japan. Some of the key developments include:

Agência Nacional de Vigilância Sanitária (ANVISA), or the Brazilian Health Regulatory Agency/National Health Surveillance Agency, approved Apretude® (cabotegravir), in both tablet and injectable dosage forms, on June 05, 2023, for the prevention of Human Immunodeficiency Virus (HIV) viral transmission. (New Drug for HIV Prevention) Apretude® is only recommended for individuals who weigh at least thirty-five (35) kilograms.

The European Regulatory landscape presents a myriad of challenges and opportunities for pharmaceutical companies seeking to bring their products to the market. Navigating the complexities of the diverse Regulatory frameworks of the region, the varied linguistic requirements, and the ever-evolving guidelines requires a well-executed staffing strategy.

In this blog, we shall explore the key considerations and effective strategies for optimizing Regulatory affairs staffing in Europe, which in turn enable companies to navigate the intricacies and achieve Regulatory success.

Digital therapeutics, also known as software-based therapies, have gained significant attention as an alternative treatment option for various chronic diseases. With improved patient outcomes, real-time monitoring, greater accessibility and flexibility as well as cost-effectiveness, digital therapeutics has revolutionized the healthcare sector, and worldwide health agencies are currently focusing on regulating this class of devices effectively.

Effective January 31, 2022, the new European Union (EU) pharmaceutical regulation for Clinical Trials Regulation (CTR) has become mandatory, repealing the Clinical Trials Directive 2001/20/EC. The regulation harmonizes protocols for evaluating and supervising clinical trials across the EU. The guidelines were revised to promote a uniform approach to clinical research while stressing clinical trial participants’ safety and increased public disclosure.

China is a major player in the medical device industry, and with its diverse population and expanding healthcare market, companies need to understand the necessary clinical trial requirements for medical device products in this region. The Chinese government has implemented a variety of regulations to ensure the safety and efficacy of medical devices being placed on the market.

A comprehensive compilation of clinical and nonclinical data on the investigational product (drug, supplement, device, or other product) provides a brief description of the drug substance and the formulation, including the structural formula (if known). An Investigator’s Brochure (IB) is an essential document maintained by a drug developer or investigator throughout the drug development process, and it contains the body of information acquired before and throughout a drug trial. The IB is updated whenever new information about an investigational product becomes available.

The National Medical Products Administration (NMPA) of China recently released a comprehensive draft amendment for implementing the China Drug Administration Law (DAL). 

The draft amendment introduces significant changes to the Regulatory framework. It encodes the various Regulatory initiatives undertaken by the Chinese government since the implementation of the current China DAL, which was promulgated in 2019. The Law was intended for data protection and patent linkage.  

After nearly two (02) decades of issuing the first draft guidance, the United States Food and Drug Administration (US FDA) finalized the guidance on population Pharmacokinetics (PK) in February 2022. The latest draft explains the application of population PK in drug development and recommendations on therapeutic individualization. The guidance applies to the Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), and the Abbreviated New Drug Applications (ANDAs).

You might be aware, in the context of pending agreements between Switzerland and the EU, there are certain modifications/amendments made to the Medical Devices Ordinance (MedDO) and the Federal Council approved supplementary provisions for implementing medical device regulations, which are in force since May 26, 2021. These provisions are designed to offset the negative consequences in the absence of an MRA (Mutual Recognition Agreement) update and to ensure a sufficient supply of medical devices to Switzerland. Let us know more about these amendments.