ancer immunotherapy – a treatment that harnesses the immune system’s exquisite specificity and “memory” properties to fight cancer – has revolutionized the field of oncology in a way that could not have been anticipated just ten years ago (1).

nnovations in medical technology have led to a proliferation of transformative therapies that promise to alter treatment paradigms and even reverse disease progression. The promise of treatment outcomes can make these technologies eligible for expedited regulatory pathways that do not require extensive clinical trial data for market approval.

f you’re a stakeholder in the healthcare industry, you know the cybersecurity challenges that healthcare providers face. While data protection is a primary goal, they must ensure that patient privacy is maintained. Providers must also deliver high-quality services while conforming to strict requirements by HIPAA, the EU’s GDPR, and other legislative and regulatory bodies.

he 2nd African Medicines Regulatory Harmonization (AMRH) Week took place virtually beginning December 9, 2020, due to wide travel restrictions in many countries because of the COVID-19 pandemic. Attended by more than 120 participants from Africa and other parts of the world, these discussions included collaboration among regulators and ethics committees regarding COVID-19 clinical trials review, preparations for authorization and monitoring of the safety of COVID vaccines, as well as the listing of medical devices, including in vitro diagnostics and personal protective equipment (PPEs) as part of COVID-19 response.

he Asia-Pacific Medical Technology Association (APACMed) is the trade association for the MedTech industry in Asia-Pacific. Following the 2020 launch of its Digital Health Committee, APACMed is seeking greater harmonization on topics such as regulation, interoperability, and cybersecurity in digital health.

This paper reviews regulatory measures for digital health (DH) solutions in Singapore, Australia, Japan, and the US, and proposes a best practices framework for regulators to use as they implement fit-for-purpose regulation for DH solutions.

n the tumultuous year of 2020, the COVID-19 pandemic did not appear to hinder the progress of regulatory reform and new drug approvals in China. The National Medical Products Administration (NMPA) continued to implement many regulations and guidelines. The number of drug applications and the timeline of review and approval were not negatively impacted.

fter four and a half years of Brexit discussions and negotiations, the UK and the EU have managed to arrive at a trade agreement at the eleventh hour and avoid a hard Brexit. In the absence of an agreement, a hard Brexit would have been the default and would have had immediate and severe implications on (timely) access to medicines for patients. The deal applies provisionally as of 1 January 2021, as it still must be ratified by, among others, the European Parliament. Notwithstanding, the trade agreement is welcomed by many stakeholders in the sector as it has lessened the uncertainty around the future relationship between the EU and the UK and has allowed for more clarity on future business operations.

he International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was established in 1990 to achieve greater harmonization worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. In 2015, the organization and operations were renewed (this was called “ICH reform”) as a legal entity under Swiss law, and its name was changed to the International “Council” for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).