Navigating the Regulatory landscape can be a complex and time-consuming process for pharmaceutical and biotechnology companies. A crucial aspect of this journey is effective Regulatory submission management, which involves coordinating and monitoring timelines, adhering to best practices, and avoiding common pitfalls.
A medical device Regulatory strategy is a plan for ensuring that a medical device meets all relevant Regulatory requirements before it is marketed and used in clinical practice. This typically involves conducting pre-clinical and clinical testing to demonstrate the device's safety and effectiveness and submitting the results to Regulatory authorities for review and approval.
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 medical device industry is undergoing continuous transformation to comply with the ever-changing Regulatory guidelines introduced by global Regulatory authorities to ensure strict controls over device performance and safety. In such a scenario, having a better understanding of the medical devices, Regulatory Affairs, and updated Regulatory information to design and implement a strategy can result in reduced costs, time-to-market, and maximum compliance.
Regulations stand crucial for any industry that functions in the Life Sciences domain, which is the third most heavily regulated sector after the Aviation & Financial sectors. Non-compliance with regulations comes at a high cost – the patients’ lives, heavy economic penalties, or loss of reputation. But challenges to this sector comes from various areas.
Introducing innovative products across global marketplaces is imperative for life sciences companies to ensure profitability and maintain their presence in the market. Regulatory compliance and authorizations being the key factors behind any winning launch, inadequate Regulatory information can trigger an increase in costs and time-to-market.
Life science companies face massive challenges while constantly staying ahead of dynamic Health Authority (HA) updates. In addition, it requires multiple recurring and time-consuming processes. The traditional exercises are cumbersome and laborious, proving that Regulatory operations are costly, complicated, and slow. The ever-changing sphere of HA regulations makes it arduous to keep track and adapt at the same pace.
Hair colorants are classified as cosmetic products by the European Commission (EC) and are regulated under the regulation (EC) No: 1223/2009. Hair colorants contain a mixture of substances called hair dyes that are used to change the color of hair or to restore the original hair color. They are classified into the following three (03) categories based on their color fastness:
Sustaining the ever-evolving global Regulatory space of the life sciences industry is strenuous. Therefore, it is necessary for manufacturers to keep abreast with the latest Regulatory information to ensure compliance across all the business functions, such as clinical development, release, and marketing scrutiny of medicines.
While the world is tussling with COVID-19 pandemic, there’s an emergency need for its treatments and vaccines. Though, currently, there is no FDA approved therapy or vaccine for COVID-19, the agency has several tools to expedite the review and approval of a COVID-19 biologic treatment or vaccine, after it emerges.