Global Regulatory Changes in Biopharma

Evolution in Global Pharmaceutical Regulatory Landscape & Notable Changes for Sponsors

Pharmaceutical companies must comply with regulations set forth by respective regulatory agencies right from the pre-clinical to post-marketing phases of clinical development. Each regional agency has a wide array of stringent guidelines for various processes to ensure patient safety and product quality. With changing industry trends, new regulations are bound to be set forth to further enhance medical research.

The changes in any regulatory regime tend to have a major impact on the sponsors and it becomes the sponsors’ responsibility to track the revisions/modifications from time to time to adapt and align with them. After COVID-19, global regulatory agencies have made some notable changes in regulations based on the unforeseen challenges, key learnings and various observations from the development, manufacturing, and delivery of vaccines.

Listed below are the notable changes in different types of regulations from major regulatory bodies around the world.

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USA – United States Food and Drug Administration (US FDA)

With increasing concerns around patient safety, and growing need for expediting the review process, the US FDA has is planning to introduce the following changes:

Framework to Use Real-world Evidence to Mitigate ‘Off-label’ Drug Usage

The US FDA introduced framework to incorporate real-world evidence to mitigate the “off-label” drug use in regulatory approvals and thus create a rigorous safety profile. The framework was brought forth using provisions made available in the revolutionary ‘21st Century Cures Act’. Off-label drug usage for an unapproved indication could result in adverse events that could be tough to understand and address. The agency is seeking to track real-world evidence to not only to regularize and control such usage, but also to track the usage of product for new indication and in-time allow for its approval should it prove beneficial.

CMC Post-approval Changes for Biologics

Revised guidance for ‘CMC post-approval changes for biologics’ under which the categories of major, moderate and minor changes in the manufacturing process, the drug substance purification process, the starting materials and the container/closure system have been established. This CMC guidance update comprises of other changes such as inclusion of word ‘intermediate’ in glossary as per industry body suggestion, and an appendix recommending categories for manufacturing changes that are commonly reported.

Emergency Use Authorization for Vaccines to Prevent COVID-19

Under Emergency Use Authorization (EUA) the FDA has paved way for faster approval of vaccines. New guidelines for studies and review of COVID-19 specific vaccines have been issued. This guidance combines other guidelines issued independently and develops a comprehensive set of recommendations for biologics sponsors planning to market/ currently marketing their product in the USA. This guidance in its final version shall remain active only for the duration of the current public health emergency (COVID-19 pandemic) and might become void unless the agency issues further guidelines. The sponsors are required to include the following details before submitting a request for EUA to market their vaccine.

  • Description of product along with its intended use in detail
  • Safety and efficacy data about the product (currently available)
  • All available information about risks and benefits including steps to mitigate risk, recommendations for safe use, contraindications and other essential information the sponsor might possess.
  • Need for the product, alternative approved products and adequacy for proposed use
  • CMC data, information about manufacturing facility, any existing safety and efficacy data

The guidance, formats and data points discussed above are sensitive in nature and must be understood and acted upon using professional assistance. Our regulatory affairs and medical writing experts could provide the right guidance and help for you to get an approval under EUA or in general format from the FDA.

European Union – European Medicines Agency (EMA)

Clinical Trial Regulation (CTR) & CTIS Portal

A major guidance for regulating clinical trials by the EMA, the Clinical Trial Regulation (CTR) introduces multiple proposed changes. The CTR changes will result in harmonization of assessment and supervision processes across all EU trials, support sponsors achieving approvals in multiple EU regions with greater efficiency, and protect and improve patient safety. A brief summary with important changes is listed below.

  • The CTR categorizes the clinical trial studies into three types – clinical trials, non-interventional studies and low-interventional clinical studies
  • Auxiliary medicinal products will replace the existing terminology non-investigative medicinal products (NIMP)
  • CTR will allow for the submission of a single application dossier to multiple EU countries, through a single portal controlled by the EMA
  • Substantial modifications (replacing substantial amendments) will be similarly submitted through the Clinical Trials Information System (CTIS) portal
  • Although no date has been set, EMA is aiming to go live with CTIS by January 21, 2022
  • Suspected unexpected serious adverse reactions (SUSARs) submission process will be simplified with the submission being made through the EMA database which will then be forwarded on to member states
  • A summary of the clinical trial results must be submitted within one year after completion of clinical trials in all member states, accompanied by a layperson summary
IDMP Implementation Guide

EMA has recently published the second version of Identification of Medicinal Products (IDMP) Implementation Guide. The guide is referred for understanding and complying with regulations for submitting data on medicinal products and it defines the implementation requirements of the ISO IDMP standards and terminologies in the EU. The guidance imparts information about the timelines, requirements, processes, technical specifications, data elements and associated business rules for the stakeholders. The latest revision of IDMP Implementation Guide has additional information about the following aspects.

  • High level principles of the target operating model for submission and maintenance of medicinal product data in the EU
  • Extended guidance on how to populate the PMS data elements
  • The basis for medicinal product data exchange in the EU

With both COVID-19 specific guidance and other guidelines being released in tandem, sponsors might require intelligence services to follow up on all relevant changes and adhere to them in time. Should you need regulatory assistance, Techsol is equipped with expertise of having helped multiple clients with successful submissions and approvals in the EU region and can guide you too through any regulatory challenges you might face.

Canada – Health Canada (HC)

Regulatory Innovation for Health Products

Under the Food and Drugs Act, Health Canada has proposed modernization of regulation of clinical trials by introducing the following changes.

  • Coherent risk-based approach
  • Streamline processes towards greater efficiency and clarity
  • Afford greater flexibility in the safe development of innovative therapies and products
  • Align with international best practices regarding oversight and public access to information

The proposal intends to better align Health Canada’s clinical trials framework across its business lines (human drug clinical trials, medical device investigational testing, non-prescription drugs and natural health product clinical trials, and clinical trials for foods for a special dietary purpose).

Forward Regulatory Plan 2021-2023: Modernizing compliance and enforcement oversight for drugs

Enabled by the Health Canada under Food and Drugs Act, the Forward Regulatory Plan 2021-2023 would ease the burden associated with annual licence review and modernize provisions related to compliance and enforcement tools. This proposal is expected to increase regulatory decision-making efficiency and predictability concerning drug establishment licences, allowing an opportunity for industry stakeholders to streamline their compliance programs accordingly.

Two major reforms that have come from this plan are discussed briefly with precedent for sponsors to review the changes.

  1. Set forth as part of Forward Regulatory Plan discussed above, the Interim Order No. 2 introduces regulatory flexibility to allow for broader types of COVID-19 clinical trials to take place more efficiently and to facilitate broader patient participation across the country. The new proposal also:
    • Reduces administrative requirements for assessing the use of existing marketed products as possible COVID-19-related therapies
    • Allows alternate means of obtaining patient consent
    • Broadens the criteria of qualified health professionals who can carry out qualified investigator duties at remote sites
    • Expands the range of applicants who can apply for a medical device clinical trial authorization
  2. Another major amendment provisioned through the Forward Regulatory Plan is to establish pharmaceutical equivalence between generic products with certain different physical or chemical forms of the medicinal ingredient. This initiative will align Canada’s approach with other international regulatory authorities that allow certain differences in the medicinal ingredient.

Navigate through the Health Canada’s complex regulatory regime towards compliance with expert assistance from Techsol for submissions and aligning with upcoming regulatory changes.

Japan – Pharmaceuticals and Medical Devices Agency (PMDA)

Regulatory Framework for Regenerative Medicines

The new Regulatory Framework for Regenerative Medicines defines regenerative medicines and establishes the guidelines to conduct studies for them under the PDM Act. This Act reduces the phased clinical trial period for regenerative medical products allowing them to be used on a conditional authorization basis, should there be a need. The facilitation of thorough regulation for this process is a major step forward for scientific regulation with the provision of early patient access to promising regenerative products. The data and knowledge gained from the clinical trials and post-marketing studies will help to identify issues to improve scientific regulations for approval of novel drug and medical device products.

Pharmaceuticals and Medical Devices Safety Information No. 382

In April, 2021 PDMA has released safety information about Pharmaceutical and MedTech products on using PI* Navi – a smart phone app used to access digitized PIs. Additionally, PDMA issued guidelines for digitization of reports for adverse events from medical institutions.

(*PI – Package Insert)

Approaching PDMA is often riddled with linguistic challenges and requires expertise and liaison capabilities simultaneously. Map out your medicinal product and medical device end-to-end submission process for PDMA with Techsol’s assistance.

Australia – Therapeutic Goods Administration (TGA)

Australian Unique Device Identification (UDI) System

Aligning with global device identification systems, TGA is implementing its own UDI system to support manufacturers and sponsors of medical devices marketing in Australia in tracking their products throughout the supply chain and inventory management functions. Through UDI, TGA aims to reduce manual error in post-market surveillance and eliminate confusion in identifying the models of devices on both national and global basis. Currently, TGA’s UDI system is in early stages. The system could come into implementation only after EU completes implementing the same as TGA plans to align with EU’s system.

Other Regulatory Reforms

To accommodate regulation of evolving therapeutics and simplify regulatory processes for sponsors, TGA has come up with major regulatory reform activities for 2020-21.

  • TGA will continue to expand and evolve work-sharing product evaluations of new prescription medicines, extensions of indications to medicines and generic medicines with Australia-Canada-Singapore-Switzerland consortium (ACSS) partners and joint evaluations of new oncology medicines with the USA and Canada through Project Orbis
  • TGA is implementing a new therapeutic goods order (TGO 106). The TGO includes the standards for serialization and data matrix codes on medicines using which they can be better identified throughout the supply chain

Gain lead in medicinal and medical device market of Australia compliantly with Techsol’s assistance for regulatory affairs and CMC processes.

How Techsol can help Pharmaceutical Companies remain compliant throughout their Drug/ Product Lifecycle?

As regulatory agencies continue to introduce changes across the globe, Techsol can provide a robust, transparent, and efficient regulatory framework that will deliver safe and effective innovative medicinal products to patients in a compliant manner.

Sponsors might find it challenging to track, categorize and implement region-wise regulations to continue to align with evolving global regulatory framework. In order to keep up with the ever-evolving international and national policies, Techsol can assist the Pharmaceutical companies to continue to remain compliant throughout. To that end, our regulatory experts shall,

  • Provide insights on regulatory issues global regulatory affairs
  • Plan and implement best practices for quality, risk, and regulatory related operations
  • Develop a robust Compliance Lifecycle Management framework

Our team of regulatory experts can consult and implement latest regulatory changes based on its impact on the sponsor’s current business processes, market developments, and implementation path. Should you have the need for further information about any of the region-specific regulations, feel free to contact us at

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