Stay Ahead of the Compliance Deadlines Through 2022
There appear to be encouraging advances in all corporate sectors toward growth, thanks to the rapid development of vaccines and quick immunizations in large portions of the world. However, the threat of additional COVID waves and variations continues to exist. Let’s hope we can move on from this and focus on the positive aspects of the business. Even amid these darkest times for humanity, a few business areas, such as Life Sciences, are thriving and making rapid progress.
With new scientific, operational, and technological workflows, the industry is projected to provide a lot to researchers, innovators, and even regulators. Here are a few anticipated Regulatory mandates or procedural changes we would like the industry to pay attention to as a leading Regulatory solutions and services supplier devoted to customers’ compliant global market entry. Let’s look at the Life Sciences and MedTech categories in more detail.
The European Medicines Agency (EMA) has issued new guidelines for the Nitrosamine Detected Response Template.
Pharmaceuticals
The Committee for Medicinal Products for Human Use (CHMP) has advised Marketing Authorization Holders (MAHs) to adopt the updated EMA guidance for Nitrosamine detected Response Template. The deadlines for new submissions to identify the existence of Nitrosamine levels in active substances and completed goods for the first step of Risk Evaluation were set for March 31, 2021 (chemical medicines) and July 1, 2021 (finished products) (biological drugs).
The MAHs must conduct required confirmatory testing in the presence of higher quantities of Nitrosamine than the allowed values in the second step, known as Confirmatory Testing. MAHs are required to alter the Marketing Authorization Template and submit marketing authorization amendments to the EMA by September 26, 2022 for chemical goods and July 1, 2023 for biological medicines following the second step of testing.
Medical Equipment
EMA Guidance on Drug-Device Combination Products Quality Documentation
Given the rapid pace of technology advancements and the vast range of medical devices or device parts that may be used in conjunction with a medicinal product, it’s critical to have clear criteria for what information should be included in a combination product’s regulatory submission. The European Medicines Agency (EMA) published a guidance document in August 2021 explaining how dossiers (Marketing Authorization Application (MAA) or Post-authorization Application) for medicinal products used with a medical device or a device part should be presented qualitatively. As the dossiers must be submitted in accordance with 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 updated rules will become operative on January 1, 2022.
Medical Device UDI Requirements and Deadlines Announced by the SFDA
It is commonly understood that a Unique Device Identification (UDI) is essential, and that if properly implemented, it will deliver significant and long-term benefits to medical device manufacturers, healthcare providers, and consumers. The major advantages of UDI include accurate reporting, reviewing, and analysing adverse event reports, reducing medical errors through rapid and precise identification of device characteristics, reducing counterfeiting, better device performance assessment, informed patient treatment, and providing a standardised identifier that facilitates efficient medical device recall management. However, following the particular rules set by various health agencies is critical to getting these benefits. The Saudi Food and Drug Authority (SFDA), Saudi Arabia’s medical device regulator, recently released a guidance document outlining the new UDI standards and compliance dates for Class B&C (February 1, 2022) and Class A devices (February 01, 2023).
Medical Device Guidance Documents for Fiscal Year (FY) 2022 have been published by the US FDA.
For fiscal year 2022, the FDA’s Center for Devices and Radiological Health (CDRH) has released a list of medical device guidance publications. This list of guidance documents provides transparency (in terms of where the regulator plans to devote resources and potentially increase scrutiny in the coming year, as well as how manufacturers may be impacted in terms of compliance) to medical device applicants and registrants interested in entering the US market. The FDA’s Center for Drug Evaluation and Research has categorised its list of guideline publications into three (03) divisions. The A-list is a prioritised list of device guidance documents that the FDA plans to release in FY2022. The B-list includes a list of device advice documents that the FDA plans to publish as resources allow in FY2022, and the Retrospective Review List includes a list of final guidance documents released in 1982, 1992, 2002, and 2012.
Chemicals
The EPA Updated the LCR and Mandatory Timelines – Here’s What You Need to Know
The Lead and Copper Rule (LCR) was recently changed by the US Environmental Protection Agency (EPA) to protect children and communities from the dangers of lead poisoning. The EPA wants to remove lead from drinking water and empower communities by providing accurate information.
Timelines are required.
Effective date: The final rule was set to go into effect on December 16, 2021.
The implementation date of the final rule was formerly issued on January 15, 2021, and then delayed in a rule published on March 12, 2021, when it was postponed until December 16, 2021.
The final rule’s compliance date has been pushed back until October 16, 2024.
REACH Registration Requirements in the EU
The European Commission has modified the information requirements for chemical registration under EU REACH, with the goal of increasing transparency in the European Chemical Agency’s (ECHA) evaluation methods. The EU REACH annexes have been updated to describe the information necessary for companies to submit during the registration of chemicals. The law took effect on July 8, 2021, and will remain in effect until January 8, 2022.
Chemical Substance Registration in South Korea
Chemical regulations in South Korea are overseen by a number of ministries, including the Ministry of Environment, Ministry of Employment and Labor, Ministry of Health and Welfare, Ministry of Agriculture, and others, and are governed by a number of laws governing chemical applications and hazards. The goal of all authorities is to protect human health and the environment against chemical harm. The modified K-REACH Act was issued in March 2018 and took effect on January 1, 2019. K-REACH requires every company intending to import or manufacture a new chemical substance or an existing chemical substance to register.
New substances must be registered before December 31, 2024, for existing chemical substances manufactured or imported up to 100-1000 tonnes per year, and before December 31, 2030, for existing chemical substances manufactured or imported up to 1-100 tonnes per year, according to the modified K-REACH.
Important Deadlines and Poison Center Notification
Poison Control Centers are responsible for gathering pertinent information regarding hazardous mixes and providing medical advice in the event of a health emergency. ANNEX VIII of the CLP Regulation was implemented to address the varying notification systems and information requirements across the EU. Its goal is to standardise the hazardous information and format that must be supplied to Poison Control Centers in order to enhance emergency response times.
The notification obligations for importers and downstream users who seek to place hazardous chemical mixtures on the EU market are described in Article 45 of the CLP Regulation. From January 1, 2024, all industrial mixtures must comply with the new requirements. From January 1, 2025, mixtures that have already been placed on the market and disclosed under national legislation must comply.
The Environmental Protection Agency (EPA) will develop New Approach Methods (NAMs) to reduce animal testing of chemicals.
The US Environmental Protection Agency is focusing on developing and implementing New Approach Methods (NAMs) for chemical testing. This innovative approach will assist to reduce the use of animals as test subjects in chemical research while also maintaining human health and environmental protection. Animal testing alternatives are equivalent to NAMs. This action demonstrates how the EPA is working toward its objective of eliminating animal experimentation in chemical testing by 2035. As a result, stakeholders must stay informed about impending animal testing rules and take appropriate action.
Food and dietary supplements
Nutraceutical Regulations Revised by the FSSAI
On January 1, 2018, 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 took effect. The FSSAI recently amended the aforesaid regulations for the first time, with the permission of the Central Government.
These rules apply to the following eight (08) types of functional foods:
Supplements for Health
Nutraceuticals
Specialty Foods Containing Plant or Botanicals Foods Containing Probiotics Foods for Special Dietary Use
Novel Foods that include prebiotics
From April 1, 2022, all Food Business Operators (FBOs) must comply with the provisions of these laws.
Cosmetics
European Green Deal’s Effect on the Cosmetics Industry Maintaining good climatic health is one of every individual’s top concerns, and numerous groundbreaking improvements have been implemented around the world to mitigate the effects of climate change. Europe as a continent has launched the European Green Deal to line with this. The idea aims to create a new growth strategy and transform the EU into an environmentally friendly and competitive economy. By 2050, according to this new concept, there will be no net emissions of greenhouse gases. The European Green Deal’s major goal is to make the European economy sustainable by focusing on achieving carbon neutrality by 2050.
To summarise, the Life Sciences and MedTech industries will have a plethora of chances in 2022. For a successful market launch, it is critical for industry stakeholders to follow updated rules and keep a close eye on the details of each Regulatory step, from strategy to submissions.
With a staff of 1100+ regulatory specialists and over ten (10) years in the sector, Freyr has successfully aided 850+ worldwide clients in satisfying their compliance obligations across 120+ countries. Do you want to know how we accomplished it? It is our pleasure to walk you through the process and many regulatory scenarios we have encountered. Let’s start the chat right now. Please contact us.
Category : Regulatory Services, Regulatory Affairs, Pharmaceuticals, Medical Devices, Food And Food Supplements, Chemicals, Cosmetics Regulatory Services.
Key Words : TAGS: 2022 Regulatory Updates, Regulatory Outlook 2022, Global Regulations, Regulatory Affairs, Pharmaceuticals, Medical Devices, Cosmetics, Chemicals, Food & Food Supplements, Regulatory Affairs, Regulatory Affairs, Regulatory Affairs, Regulatory Affairs, Regulatory Affairs,
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