2020 and Farther A Regulatory Sneak Peek

It has been observed for long that innovation drives the life sciences industry, and this would continue perpetually. For the betterment of human health, there have been many innovative drugs/devices released into the market. For good, some of them shaped the humankind well, but alas some had to be taken off the market due to their adverse reactions and manufacturing and Regulatory procedural setbacks. To reduce the adverse reactions and to ensure each innovative product achieves its ultimate goal of protecting human health, global health authorities, as always, are evolving their regulations and paving Regulatory pathways. In addition, they are continuously laying enormous efforts to educate the industry about upcoming Regulatory scenarios. EMA’s Regulatory Science 2025 and Pharmacovigilance 2030 are a few of them. We agree, they seem pretty long term. But they act as stepping stones. Aren’t they?

Likewise, many pre-eminent health authorities around the world are updating their regulations. As we just started with 2020, we would like to give you a better perspective on global regulations pertaining to Pharmaceuticals, Medical Devices, Cosmetics, Food and Food Supplements etc. In simple terms it is just a Regulatory heads up for successful compliance in 2020 and farther. Let’s take a look at comprehensive list of industry-wise upcoming Regulations.

Regulatory Updates 2020 - Pharmaceuticals

Health Canada to Implement eCTD Format for DMF Submissions

As per the latest update by Health Canada, mandatory eCTD format for DMFs will be effective from January 1, 2020. The aim of introducing this mandate is to streamline the submission process for the HC and align with the global Regulatory authorities.

In order to align and comply with the latest advancements of the Health Canada, DMF holders must use eCTD format for all the Regulatory activity types as mentioned below:

  • New Type I Master Files – Drug Substance
  • New Type II Master Files – Container Closure Systems and Components
  • New Type III Master Files – Excipients
  • New Type IV Master Files – Drug Products

Conversion of non-eCTD DMFs into eCTD format is not mandatory.

EDQM to Mandate eCTD Format for CEP Applications

As a part of the revised roadmap (2016-2020), the European Directorate for the Quality of Medicines and Healthcare (EDQM) released a notification stating that eCTD format will be mandatory for the submission of Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) applications.

The eCTD format is said to be effective from January 1, 2020. Post the stated date, EDQM will not accept any NeeS submission for CEP applications including notifications, renewals and revisions.

TGA’s Labeling Requirement and the End of Transition Period

The Therapeutic Goods Administration (TGA) introduced new labeling requirements for medicine labels, which came into effect from August 31, 2016. The changes in the labeling requirements were made in order to align with the industry best standards and help the consumers to make an informed choice. The agency has given a transition period of 4 years to the sponsors to align with the new labeling requirements. The transition period will end on August 31, 2020, post which all the medicine labels must meet the requirements of the new labeling rules.  

FDA’s Extension for DMF Type III eCTD Submission

After pushing the deadline for submission of DMF type III in electronic format twice, the Food and Drugs Administration (FDA) has finally extended the deadline until May 5, 2020. Post the deadline, DMFs submitted in non-eCTD format will not be accepted by the FDA. However, if a DMF is already submitted to the FDA in paper format, it need not be submitted again in electronic format.

TGA’s New Product Information (PI) Form

On November 8, 2017, the Therapeutic Goods Administration (TGA) approved a new Product Information (PI) form for medicines. The PI forms were mandated from January 1, 2018, and the sponsors were given a transition period of two years that ends on December 31, 2020. The advancements in the PI form were also a result of TGA’s efforts of aligning with global formatting requirements. Key changes in the new PI form include:

  • Reordering the content in order to prioritize the critical information
  • Updating headings and sub-headings to align with the globally-used standards

TGA’s Changes to Ingredient Names

The transition period for aligning with the updated medicine ingredient names will be ending on April 30, 2020. From May 1, 2020, all the medicine sponsors will be required to reflect the updated ingredient names on the medicine labels. Sponsors are required to follow the below-mentioned instructions for medicines before the transition period ends:

  • Existing products – For medicines that are already in the market, sponsors are required to update their labels and supporting documents to reflect the new ingredient names by April 30, 2020.
  • New Products – All the new products registered with the TGA are required to meet the requirements of new ingredient names.
  • Registered Medicines – For registered medicines, sponsors are required to submit a copy of updated label and product information document to the TGA.
  • Listed Medicines – Sponsors do not need to submit a proof of label change to the TGA.

Regulatory Updates 2020 – Medical Devices

EMA’s New EU MDR Will Be Effective From May 26, 2020

The next six months are crucial for the Medical Device (MD) industry as EMA's new EU MDR is scheduled to come into full implementation mode on May 26, 2020. The EU MDR is expected to create a robust, more transparent, safe monitoring and secured Regulatory framework for the supply of medical devices. Till May 2020, manufacturers can either comply with the existing MDD Regulatory requirements or align with the new MDR. However, post May 2020, they will have to renew their existing CE certificates, and all the new devices must be aligned with the new MDR. Manufacturers also need to define pathway strategies for Regulatory submissions and need to create a post-market surveillance (PMS) plan to monitor the safety profile of the products.

CDSCO Makes Addition to the List of Regulated Medical Devices

To ensure efficacy and safety of medical devices, the CDSCO drafted and published the Medical Device Rules – 2017. To further aid this, on Feb 8, 2019, the CDSCO has recognized and added 8 new device types. Previously, the CDSCO had added 4 other devices to the list and mandated the manufacturers to register them as per the new list before January 1, 2020.

From April 1, 2020, manufacturers and new market entrants willing to sell the newly listed regulated medical devices in the country are required to register with the local health authority CDSCO and foreign manufacturers must obtain an Import License to import and market in the country.

Regulatory Updates 2020 - Cosmetics

Australia Imposes Ban on Animal Testing

In 2019, the Australian government passed a bill imposing a complete ban on testing of cosmetics on animals. The Industrial Chemical Bill 2017 of the Australian government includes a ban on the animal tests of cosmetic ingredients for collection of relevant data. The ban is also applicable on the cosmetic ingredients used in another product sector. However, it is not applicable to medical testing and ingredients that have been tested in the past. Cosmetic manufacturers are given a deadline until July 2020 to align with the new regulations.

Regulatory Updates 2020 - Food and Food Supplements

Changes to FDA’s Nutrition Facts Label

In 2016, the United States Food and Drug Administration (US FDA) published final rules for Nutrition Facts Label for packaged food. The purpose of the new rule is to ensure that the product labels align with the current food habits and practices, and help the consumers make an informed choice. Food and food supplement manufacturers that are aiming to enter the US market must meet these new revised labeling rules in order to stay compliant.

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. While many of the food product manufacturers have already started complying with the new rules, rest of the manufacturers with an annual food sales of more than USD 10 million have time till January 1, 2020.

FSSAI Re-categorizes Health Supplements as the FSDU

The Food Safety and Standards Authority of India (FSSAI) has published a guidance document announcing the re-categorization of all the health supplements for sports use as Food for Special Dietary Uses (FSDU). The guidance states that going forward health supplement manufacturers in India will have to comply with the Food Safety and Standards Act, established in the year 2016. It also mentions that the health supplements for sports use cannot contain any unauthorized hormones, steroids or psychotropic ingredients. In addition to this, the health supplements will be evaluated based on the composition of vitamins, minerals, amino acids, probiotics, etc.

To sum it up, the year 2020 promises the life sciences industry a gamut of opportunities, but only when they abide by updated regulations. Mentioned above is just a tip of the iceberg. There are many more upcoming regulations for the year 2020 and may have hidden procedural challenges for compliance. Though it may sound impractical, it is necessary for manufacturers to have a keen eye on each one of the regulations to make their product launch and global market entry strategies compliant. Keep track of the global Regulatory advancements and stay compliant