Regulatory

Three key trends in regulatory approvals of new medicines

A new study by the Centre for Innovation in Regulatory Science (CIRS) has shown that despite regulatory convergence over the last 20 years, there are still differences in approval times across global regulatory agencies. The following article summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2011-2020. Three […]

What Europe’s MDR means for manufacturers of legacy devices

Clarivate regulatory expert  Mónica Colina reviews key aspects of the European Commission’s Medical Device Regulation (MDR) to be considered for surveillance audits of medical devices certified under the repealed directives.  The European Commission’s Medical Device Regulation rules, first published in May 2017, became applicable in all European member states in May of this year. The […]

Volume-Based Procurement in Mainland China: Key trends and planning future strategies

Mainland China has gone through a series of regulatory and reimbursement reforms in recent years in an effort to keep pace with its dynamic economic and demographic landscape. Clarivate expert Karan Verma discusses how the Volume-Based Procurement program is transforming the generics landscape, increasing patient access and prompting manufactures to rethink strategies.   Remodeling Mainland […]

Mainland China’s NRDL: The expensive yet priceless ticket to market access

Recent updates in the NRDL highlight Mainland China’s improving market access and reimbursement environment for innovative therapies. However, this comes at the cost of heavy price cuts that manufacturers must offer in exchange for NRDL inclusion. Are these price cuts worth gaining market access in Mainland China? What other trends have emerged from the recent […]

Mainland China’s anticipated biosimilar boom – potential and key drivers of the market

The market of major biologics in Mainland China has tripled since 2017, with the potential to grow five-fold over the next ten years – which could drive biosimilars growth. Clarivate expert Akash Saini discusses this market’s potential and key drivers.    The approval of Shanghai Henlius Biotech’s HLX01—a biosimilar of rituximab (Roche’s MabThera)—in February 2019 […]

Regulatory response to the COVID-19 pandemic: Fast tracking therapeutics

The efforts to end the COVID-19 pandemic have been multifaceted: epidemiological data for understanding, vaccines and non-pharmaceutical interventions for prevention, and new or repurposed drugs for treatment.  In this blog post, Monia Tumminello, Manager, Cortellis Regulatory Intelligence™, and Jaime Polychrones, Medical Writer, Cortellis Regulatory Intelligence, discuss the regulatory response to therapeutic development, from issuing new […]

Regulatory response to the COVID-19 pandemic: Prevention via non-pharmaceutical intervention

Preventive strategies for COVID-19 include a variety of non-pharmaceutical interventions (NPIs) such as social distancing and the use of personal protective equipment (PPE). Reliable case identification and contact tracing guide the distribution of supplies and implementation of NPIs. In this blog post, we discuss how regulatory agencies have addressed the ongoing need for NPI, PPE, […]

Regulatory response to the COVID-19 pandemic: Careful planning to minimize disruptions

Beyond the need to address the ongoing pandemic itself, regulators also must address the impacts to clinical trials as well as essential supplies of treatments and medicines for other diseases and conditions. In this final blog post of our series, we describe strategies to minimize disruption to ongoing clinical trials, drug manufacturing and essential supplies […]

2019 trends in regulatory approvals of new medicines

A study by the Centre for Innovation in Regulatory Science (CIRS) has identified trends in approvals of New Active Substances (NASs) by six major regulatory authorities1 , focusing on 2019 as well as the period from 2010 to 2019. In addition to tracking the number of approvals and the time to approval, the study also […]