After the United States Food and Drug Administration (US FDA)’s guidance document, titled ‘Integrated Summaries of Safety and Effectiveness (ISS/ISE): Location Within the Common Technical Document,’ was released in April 2009, the significance of Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) increased. ISS and ISE are pre-approval Regulatory submission documents for new drugs and biologics.
DYK? The National Medical Products Administration (NMPA), along with China National Intellectual Property Administration (CNIPA), has released “Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial)." It is a patent registration platform for chemical drugs, biological products, and traditional Chinese medicines. Along with this, the measures will also help by offering opportunities for market approval based on registered patents and judgment outcomes for chemical entities.
In the era of personalized medications, precision medicine revolutionized the delivery of biologicals, ensuring safety and efficacy by comprehending the product’s effect at an individual level. Pharmacogenomics (PGx) is one of the components of precision medicine owing to its role in optimal dose selection and effective, dose-responsive, individual identification that can avoid adverse reactions.
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.
Medical writing refers to writing scientific documents by specific healthcare professionals for various purposes, including Regulatory submissions. The global medical writing market was valued at USD 3.6 billion in 2021 and is expected to reach USD 8.4 billion in 2030, growing at a CAGR of 10.41%. In 2021, North America ruled the market due to the growing number of drug trials and new drug approvals. The Asia Pacific region is anticipated to witness astonishing growth by the end of 2030, owing to the availability of inexpensive labor and the existence of English writers.
To promote global convergence among the Health Authorities and encourage the Member States to strengthen their Regulatory system on Cell and Gene Therapy products regulations, the WHO (World Health Organization) proposed a risk-based framework for regulating Cell and Gene Therapy Products (CGTPs).
Over time, there have been huge developments in medicines and biologics sectors, and so have the changes in their respective Regulatory regimes and manufacturers’ responsibilities. On similar lines, recently, the TGA issued guidance describing the responsibilities of manufacturers of medicines and biologics. It is a step-by-step guide for:
Biologicals are booming as therapy and have significantly become an established treatment option to provide ailment to niche disease segments which seemed impossible earlier. COVID-19 pandemic has made researchers keen to develop biosimilar and interchangeable products for the patient population at an affordable price. The procedure to attain a biosimilar and interchangeable status is rigorously structured by the FDA to ensure that the quality of the preparation remains significantly unchanged.