Navigating the world of Regulatory Affairs in the Life Sciences industry can be a challenging task. One of the most critical components that organizations must manage effectively is the implementation of Current Good Manufacturing Practices (cGMP) that are compliant with the Quality Management System (QMS). However, with strategic planning, careful execution, and an understanding of the key factors involved, achieving this is more than feasible.
On May 11, 2022, Japan’s Diet passed the ground-breaking “Act on Promotion of Economic Security by Integrated Implementation of Economic Measures” apropos to the government’s policy push reform considering the global unrest and increasing geopolitical risks.
In talks since 2021, the Act was finally approved on May 11, 2022. It is expected to enter into force on or before February 18, 2023.
Overview of the Act
The framework of the Economic Security Law is based on four domains that drive the policy and are as follows:
The pharmaceutical and Life Sciences sectors have seen a steady increase in the need for Medical Writing. Patents have been expiring, Regulatory standards have changed quickly, and spending on research and development has been rising constantly. Because of this, the necessity to continuously adapt, produce, maintain, and update medical material has evolved.
The post-pandemic world is realizing that the intersection of technology and a traditional way of doing business already exists with us. The highly competitive nature of our business only exemplifies the need of incorporating innovative technologies to augment and support customers in the ever-evolving Regulatory landscape. Trends show that the global automation market, especially in the life sciences industry, is poised to grow close to $2.5 bn by 2025 with a CAGR of approximately 7.5%.
Isn’t it interesting to see Artificial Intelligence (AI) sculpting out to have a thriving position in the Regulatory landscape? One of the most important reasons for this advancement is the ability of AI and Machine Learning (ML) applications to tackle everyday procedural challenges and logical issues that compliance officers put up with.
The changing landscape of the life sciences industry makes it necessary for the companies to adapt to the global Regulatory requirements, immediately. Companies need to evolve themselves for the necessary transition with each mandatory requirement from the health authorities. One such mandatory requirement in recent times is the Electronic Common Technical Document (eCTD) format, an electronic equivalent to the Common Technical Document (CTD) format.
Drug development is an extensive and multifaceted process. In each phase of the development, manufacturers are obliged to demonstrate the safety and efficacy of their drugs in the form of Regulatory submissions. These submissions are intended to report how drug companies manufacture their drugs, design clinical trials, report safety findings, and create promotional material. The entire process involves near-constant correspondence between Regulatory affairs departments and the global Health Authorities (HAs).
Health Canada (HC) announced the revision of the validation rules for Regulatory transactions in electronic Common Technical Document (eCTD) format and published them as Version 4.4 on March 6, 2019. The Agency reported that the latest version of the rules, meant to educate the stakeholders in preparation and submission of Regulatory transactions in eCTD format, will be effective from March 30, 2019.
The revised validation rules are built on the information provided in the below-listed guidance documents:
Health Canada (HC) has one of the most stringent regulations for medical devices. To further increase the safety and effectiveness of devices, and optimize the health outcomes for end-users, the Canadian health authority (HA) is aiming to strengthen the current Regulatory framework. The three-part strategy announced recently as an action plan is the part of the same. The aim of the action plan is to take the end-users’ perspective into consideration while developing policies and regulations in future and thus to improve communication.
Artificial Intelligence (AI) is paving the way for innovative medicinal products and advanced medical devices. It is gradually headed towards decreasing repetitions in clinical trials, increasing the accuracy in drug designing processes and disease identification, personalization of patient diagnosis etc. But unless the Regulatory constraints are eliminated, the AI will fall short of reaching its full potential in Life Sciences.