二月 9, 2021
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 industry had seen amended regulations to ensure that demand for essential medical and medicinal products, such as PPE kits, surgical masks, hand sanitizers, etc., was met successfully. The global Health Authorities also introduced expedited pathways for vaccines and other products to help manufacturers reach the markets in a shorter span of time.
Due to the chaos that ensued, the year 2020 has well-prepared the industry for the upcoming year 2021. Right from amending existing regulations to devising new regulations altogether, the global Health Authorities are working continuously to improve the overall Regulatory scenario and are releasing new guidance documents, pathways, regulations and rules for medical devices, pharmaceuticals, cosmetics, food supplements, chemicals, etc. In addition to this, there are a few Regulatory updates, such as EU MDR, that are going to come into effect in 2021, which was earlier postponed due to the COVID-19. To help you get acquainted with the evolving scenarios, here we collated some of them which may impact your Regulatory strategies for 2021. Let’s take a look.
Regulatory Updates 2021 – Pharmaceuticals
MHRA Post-transition Guidance for PV, QPPV and PSMF
Medicines and Health Regulatory Authority (MHRA) of the United Kingdom (UK) published guidance for pharmacovigilance procedures and post-transition requirements for Qualified Person Responsible for Pharmacovigilance (QPPV) and Pharmacovigilance System Master Files (PSMF) for the UK authorized products. The MHRA announced that the responsibility for pharmacovigilance will be retained across the UK, and all the Marketing Authorization Holders (MAHs) must have a QPPV residing and operating in the EU/UK permanently from January 1, 2021.
Water for Pharmaceutical Use - EMA’s Revised Guidelines
To enhance the quality of the Pharmaceutical water, the European Medicine Agency (EMA) updated the two-decades-old EMA's 'Note for Guidance on quality of water for pharmaceutical use'. The new set of guidelines will come into effect from February 2021.
The major concern behind the revision of the guidelines is to control the microbial quality of water, which is a key resource for the development and maintenance of water purification systems. The European Pharmacopoeia signifies quality standards for grades of water for pharmaceutical use that includes water for injections (WFI), water for preparation of extracts and purified water.
Post-Brexit Compliance with Clinical Trial Rules
The European Commission (EC), along with the European Medicines Agency (EMA), released a notice to remind clinical trial sponsors to comply with the EU clinical trial rules following the Brexit transition period that is going to expire on 31 December 2020.
As there is no possibility for further extension of the Brexit transition period, the EC has released a Brexit readiness notice for clinical trials. The sponsors are expected to abide by the following rules to ensure smooth operation of their ongoing clinical studies:
- They must have a qualified person established in the EU or EEA or a legal representative established in the EU
- Investigational medicinal products used in clinical trials must be imported to the EU only after the qualified person certifies the batch-release
- Sponsors of all ongoing trials must also establish a qualified person in the EU
Regulatory Updates 2021 – Chemicals Safety and Regulatory Affairs
Rising Demand for Chemicals and The Need for Best Practices
Based on the infographic provided by the American Chemistry Council (ACC), explaining the contribution of chemicals to cleaning products and medical equipment, chemicals contribute:
- 75% - in cleaning compounds
- 27% - in medical equipment
- 25% - in medical supplies
This clearly shows the high demand for chemicals in the industry. With the increasing demand, there are best practices chemical manufacturers must follow both from the Regulatory and operational perspectives, such as:
- Adherence to the Dynamic Regulations
- Management of Manufacturing and Operational Data
- Minimizing Formula Costs to Create New Efficiencies
- Recalls and Quality Audits
Biocidal Products & Authorization in Europe
Biocidal product regulation (BPR) aims to ensure a high level of protection for humans and the environment and improve the functioning of the Biocidal products’ market in the European Union (EU). All Biocidal products must require authorization to enter the European market. Also, the active substances present in that Biocidal product must be previously approved. The European Commission has provided several authorization processes that are as follows:
- National Authorization and Mutual Recognition
- National Authorization and Mutual Recognition Renewal
- Union Authorization
- Simplified Authorization
- Same Biocidal Product Authorization
Regulatory Updates 2021 – Medical Devices
Role of MHRA and Post-Brexit Scenario for Medical Devices in the UK
As you may know, the Brexit transition period ended on December 31, 2020, and the UK’s Regulatory Authority, Medicines and Healthcare Products Regulatory Agency (MHRA) has taken over the current EU responsibilities for medical devices and In vitro diagnostics (IVDs), from January 1, 2021. Accordingly, the MHRA published a guidance on the new rules that will govern the regulation of medical devices and IVDs placed in Great Britain (England, Wales and Scotland), Northern Ireland and the EU market, post the transition period (however, different rules will apply to Northern Ireland). The MHRA guidance provides information on how the UK system will operate for device certification, conformity assessment and registration with the MHRA.
Medical Devices Labeling Requirement for the EU MDR Compliance
As the EU MDR transition deadline is inching closer, i.e., May 2021, manufacturers must execute the labeling requirements with utmost priority and caution and must ensure high standards of quality and safety for compliance. Prior to execution, understanding the new labeling requirements and accurate implementation is of paramount importance. Any labeling errors can impede the progress, and cause product recalls, which may lead to costly delays. Therefore, the key is to carefully prepare the medical devices labels aligning with the EU MDR labeling requirements.
Medical Device Regulation in the UK
From January 1, 2021, medical devices in the United Kingdom (UK) are regulated under the Medicines and Healthcare Products Regulatory Agency (MHRA). The new medical device regulations in the UK presents a number of changes for manufacturers to compliantly place their products in the region. Few of these changes are:
- From January 1, 2021, a new mark has been introduced in the UK known as the UK Conformity Assessed (UKCA) for assessing the safety of the products
- From January 1, 2021, the UK notified bodies will not be recognized in the European Union
- From January 1, 2021, a new registration pathway has been introduced in the UK for registering medical devices and IVDs
Regulatory Updates 2021 – Food Supplements
Changes of FDA's New Nutrition Facts Label
In 2016, the United States Food and Drug Administration (USFDA) published the final rules for Nutrition Facts Label for packaged food. The FDA established the rule to align the nutrition fact label of food products with the current food habits and practices. According to the final rules published by the USFDA, for food product manufacturers entering the US market, with an annual sale of less than USD 10 million, the labeling changes are mandatory from January 1, 2021.
The major changes in the labeling rules are related to the list of food nutrients that are required to be declared on the label of the food product, along with updating the serving size requirements and a change of design.
Regulatory Framework for Health Supplements in ASEAN
10 member states of the ASEAN region are set to finalize the Regulatory framework for health supplements in November 2021. As each country of the ASEAN region have their own set of varied regulations, this decision of the authorities aim to implement a more harmonized set of regulations for health supplement registration. The harmonized regulations will help manufacturers to distribute the same product in all the 10 member states.
Regulatory Updates 2021 – Cosmetic Products
NMPA’s Final Version of CSAR
In 2020, the National Medical Products Administration (NMPA) of China published the final version of the Cosmetic Supervision and Administration Registration Regulation (CSAR), which has come into effect from January 1, 2021. The aim of the updated CSAR is to ensure that the products manufactured and distributed in China are safe and effective for use. The key aspects of the CSAR are:
- Manufacturers are entirely responsible for the efficacy claims mentioned on the product label
- Cosmetic manufacturers are required to align by the regulations of the CSAR
- The CSAR includes a few changes in terms of classification and scope of cosmetics
- Cosmetic products will soon be regulated based on their associated risk factors
Post-Brexit Cosmetic Product Regulations in the UK
December 31, 2020, marked the end of the post-Brexit transition period between the European Union (EU) and United Kingdom (UK). As of January 1, 2021, the UK has its own Regulatory framework for monitoring the safety and efficacy of cosmetic products distributed in the market. The latest UK cosmetic product regulations are published and defined under the Schedule 34 of the UK Statutory Instrument (SI) Product Safety and Metrology regulation 2019. Similar to the EU cosmetic regulations, the UK cosmetic regulations define Regulatory requirements for placing a product in the market, compliantly, including requirements for Responsible Person (RP), Product Information File (PIF), re-labeling of cosmetic products, UK cosmetic notification portal, etc.
China’s SAMR Publishes Details of New Regulations for Cosmetic Registration
The State Administration for Market Regulation (SAMR) of China has published full details regarding the new regulations laid down for cosmetic product registration in the country. The complete text of the Administrative Measures on Cosmetic Registration and Notification comprises of six chapters and 23 articles. The new details are also in-line with the Cosmetic Supervision and Administration Registration Regulation (CSAR). The aim SAMR is to strengthen the cosmetic registration regulations and filing management to ensure consumer safety in the country. The new regulations of the SAMR will come into effect from May 1, 2021.
In conclusion, apart from the good news of worldwide vaccination for COVID-19, the year 2021 promises a plethora of opportunities for life sciences manufacturers. Above mentioned updates are just a glimpse of the upcoming changes in the global Regulatory landscape. In the wake of new normal conditions, manufacturers must be on a constant lookout for Regulatory updates to ensure compliance. With the up-to-date information, be game for 2021 with the best Regulatory strategies and compliance procedures. Stay informed. Stay compliant.
