A combination product is a therapeutic or diagnostic product that combines drugs, medical devices, and/or biological products. It combines at least two (02) of these product categories and sometimes even combines all three (03) categories. One of the key growth drivers for this market is the increasing prevalence of chronic diseases such as diabetes, cancer, and cardiovascular diseases. Combination products offer an innovative way of treating these diseases, as they can be delivered directly to the affected area, resulting in more effective treatment.

As we all know, there are continuous updates to the existing technologies alongside the advent of new ones. Incorporating these technologies into the drug-device combination products for tracking and monitoring purposes is increasing day by day. Given the continuous technological developments and wide range of medical devices or device parts that may be used with a medicinal product, it is essential to have appropriate guidelines on what type of information should be provided in a combination product’s Regulatory submission.

The year 2020 has been unpredictable for all the industries across the globe, including life sciences industry. With the outbreak of COVID-19, the life sciences industry and global Health Authorities faced various challenging scenarios, which in turn affected their long-term Regulatory plans. The global Health Authorities, along with various healthcare providers, were pushed to transform their operational models overnight to deal with the on-going crisis.

The year 2020 was a roller coaster for everyone across the world. With the outbreak of the COVID-19, global Health Authorities (HAs) have been working relentlessly to ensure that healthcare professionals and the general public have the best resources to fight this pandemic. A lot of temporary changes have been made to the regulations of various medical, medicinal and cosmetic products, such as vaccines, PPE kits, surgical masks, hand gloves, hand sanitizers, etc., to expedite their approvals and market entry, and to meet their market demand.

In the face of COVID-19 emergency, the European Medicines Agency (EMA) established faster scientific advice, rolling reviews and accelerated assessments to expedite the development and approval of medicinal products. EMA’s foresight is to support the development and marketing authorization of safe, effective and high-quality therapeutics and vaccines at the earliest.  As claimed, EMA adapts rapid procedures to significantly cut-short the Regulatory timelines for the review of new medicines and vaccines against COVID-19.

With over 5,00,000 types of Medical Devices (MDs) and in-vitro diagnostics (IVDs) existing, the European MD and IVD market stands as a major economic player. On the other side, recent scandals pertaining to certain classes of medical devices exposed the frailties of medical device regulations in the region. With the growing concerns about the weaknesses in the current system, the European Union (EU) was in plans to implement tougher rules governing the safety and monitoring of medical devices.

Today regulatory terms like eCTD, ASPPs, CANDA, SPL, MAA and NDA to name a few are the buzz words in the world of regulatory compliance. While each terminology indicates the inception of the cutting edge technology; they also come with some downright challenges for the life sciences companies. Just as in case with the regulatory submissions and publishing, if you too are wondering how to confront regulatory submissions challenges then you’re at the right place.

Do have a read and stay inspired!