Thanks to the rapid development of vaccines and quick vaccinations in major parts of the world, there seem positive developments in all the business sectors towards the growth. However, the threat is persisting in terms of new waves and new variants of COVID. Let us hope we soon get over this and see the brighter side of the business. Even in these darkest times of humankind, few business sectors like Life Sciences are recording good business growth and taking quick strides forward.
The industry is expected to offer a lot to the researchers, innovators, and even regulators, with new scientific, operational, and technological workflows. As a leading Regulatory solutions and services provider committed to customers’ compliant global market entry, here are a few upcoming Regulatory mandates or procedural changes we would want the industry to look up to. Let’s take a closer look at the Life Sciences and MedTech segments.
As per the EMA’s new guidance for Nitrosamine detected Response Template, the Committee for Medicinal Products for Human Use (CHMP) has asked Marketing Authorization Holders (MAHs) to follow the latest pathway. For the first step of Risk Evaluation, the deadlines for new submissions to identify the presence of Nitrosamine levels in active substances and the finished products were set for March 31, 2021 (chemical medicines) and July 01, 2021 (biological drugs).
For the second step, named Confirmatory Testing, the MAHs need to conduct mandatory confirmatory testing in the presence of higher levels of Nitrosamine as compared to the approved levels. For marketing authorization modifications post the second step of testing, the MAHs are expected to change the Marketing Authorization Template and make the submissions to the EMA by September 26, 2022, for chemical products and July 01, 2023, for biological medicines.
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. In August 2021, the EMA released a guidance document describing how qualitatively the dossiers (Marketing Authorization Application (MAA) or Post-authorization Application) should be presented for a medicinal product when used with a medical device or a device part. As the dossiers must be submitted following the Directive 2001/83/EC and/or Regulation (EC) 726/2004, the current guidance document focuses on the product-specific quality aspects of a medical device or device part that may have an impact on the quality, safety, and efficacy of a medicinal product. The new guidelines will come into effect from January 01, 2022.
SFDA Announced UDI Requirements and Deadlines for Medical Devices
It is well-known that a Unique Device Identification (UDI) is critical, and if implemented accurately, it will garner major and long-term benefits for medical device manufacturers, healthcare providers, and consumers. The major benefits of UDI include accurate reporting, reviewing, and analyzing of adverse event reports, reducing medical errors with rapid and precise identification of device characteristics, reduction in counterfeiting, better assessment of device performance, informed patient treatment, and providing a standardized identifier that facilitates efficient management of medical device recalls. However, the key element to achieving these benefits is to follow the specific guidelines issued by various Health Agencies. Recently, Saudi Arabia’s medical device regulator, the Saudi Food and Drug Authority (SFDA), released a guidance document stating the revised UDI requirements and compliance timelines for Class B&C (February 01, 2022) and Class A devices (February 01, 2023).
US FDA Published Medical Devices Guidance Documents for Fiscal Year (FY) 2022
The FDA’s Center for Devices and Radiological Health (CDRH) has published a list of medical devices guidance documents for the fiscal year 2022. This list of guidance documents conveys a degree of transparency (in terms of where the regulator plans to commit resources and potentially increase scrutiny over the coming year and how manufacturers may be impacted in terms of compliance) for the medical device applicants and registrants who are willing to enter the USA market. The FDA CDRH has divided its list of guidance documents into three (03) sections. The A-list consists of a list of prioritized device guidance documents the FDA intends to publish during FY2022. The B-list consists of a list of device guidance documents the FDA intends to publish as resources permit during FY2022, and the third one, which is the Retrospective Review List, consists of a list of final guidance documents issued in 1982, 1992, 2002, and 2012.
Recently, the U.S. Environmental Protection Agency (EPA) revised the Lead and Copper Rule (LCR) to protect children and communities from the risks of lead exposure. EPA aims to get lead out of the drinking water and empower communities through the correct information.
Effective date: This final rule was going to be effective from December 16, 2021.
Postponed Effective Date: Previously, the effective date of the final rule was published on January 15, 2021, and then delayed in a rule published on March 12, 2021, in which it was postponed until December 16, 2021.
Compliance Date: The compliance date for the final rule is delayed until October 16, 2024.
The European Commission has updated the information requirements for chemicals registration under the EU REACH, intending to make the European Chemical Agency (ECHA) evaluation practices more transparent. The updates of the EU REACH annexes describe the information requirements for the companies that must be submitted during the chemical’s registration. The law came into effect on July 08, 2021, and will be effective from January 08, 2022.
Chemical regulations in South Korea are managed by various Ministries such as the Ministry of Environment, Ministry of Employment and Labor, Ministry of Health and Welfare, Ministry of Agriculture, etc., under numerous laws based on the uses and hazard properties of chemical substances. All the Authorities aim to protect human health and the environment from the toxicity of chemicals. The K-REACH amended Act was published in March 2018 and came into force on January 01, 2019. Any company with an intent to import or manufacture a new chemical substance or an existing chemical substance must register under K-REACH.
Based on the amended K-REACH, new substances must be registered before December 31, 2024, to manufacture or import the existing chemical substances manufactured or imported up to 100-1000 tonnes per year, and December 31, 2030, for existing chemical substances manufactured or imported up to 1-100 tonnes per year.
Poison Centres take the responsibility to collect relevant information about hazardous mixtures and provide medical advice during health emergencies. With various notification systems and information requirements across different countries in the EU, ANNEX VIII of the CLP Regulation was implemented. It aims to harmonize the hazardous information and the format that must be submitted to Poison Centres to improve emergency responses.
Article 45 of the CLP Regulation describes the notification obligations for importers and downstream users who want to place hazardous chemical mixtures in the EU market. Mixtures intended for industrial use must comply with the new regulations from January 01, 2024. Mixtures that are already placed in the market and notified under the national legislation must comply from January 01, 2025.
The Environmental Protection Agency of the US is prioritizing attempts to develop and use New Approach Methods (NAMs) for chemical testing. This new approach will help in reducing the usage of animals as subjects in chemical testing while ensuring the protection of human health and the environment. NAMs are equivalent to “alternatives” to animal testing. This action shows how the EPA is trying to achieve the goal of eradicating the use of animals in chemical testing by 2035. Hence, stakeholders must keep abreast of the upcoming guidelines on animal testing and act accordingly.
Food & Food Supplements
The Food Safety and Standards (Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations 2016 was implemented on January 01, 2018. Recently, the FSSAI, with the previous approval of the Central Government, made the first amendment in the above regulations.
These regulations cover eight (08) categories of functional foods listed below:
- Health Supplements
- Food for Special Dietary Use
- Food for Special Medical Purpose
- Specialty Food Containing Plant or Botanicals
- Foods Containing Probiotics
- Foods Containing Prebiotics
- Novel Foods
All the Food Business Operators (FBOs) need to comply with these regulations’ provisions from April 01, 2022.
Maintaining optimal climatic health is one of the major concerns for every individual, and many revolutionary changes have been adopted across various parts of the world to slow down the effects of climate change. To align with the same, Europe, as a continent, has initiated the European Green Deal. The proposal is supposed to directly generate a new growth strategy and transform the EU into an eco-friendly and competitive economy. As per this new proposal, there would be no net emission of greenhouse gases by 2050. The main intention of the European Green Deal is to make the European economy sustainable by focusing on climate neutrality by 2050.
To sum it up, the year 2022 promises a gamut of opportunities for the Life Sciences and MedTech industries. It is crucial for the industry stakeholders to abide by the updated regulations and have a keen eye on the nuances of each Regulatory procedure, right from strategy to submissions for the successful market entry.
Having been in the industry for over ten (10) years, Freyr, with a team of 1100+ Regulatory experts, has successfully assisted 850+ global clients meeting their compliance requirements across 120+ countries. Would you like to know how we achieved this? The pleasure is ours to take you through the journey and multiple Regulatory scenarios we have been dealing with. Let us initiate the conversation now. Reach out to us.