Regulatory response & Quality Trends for 2024

Regulatory response :ICH Q9 Quality Risk Management 

Regulatory response in 2023, significant changes have impacted drug manufacturers, particularly with the revised ICH Q9 guidance on quality risk management. This has prompted companies to reassess their quality risk management plans, ensuring their effectiveness in proactively addressing issues rather than reactively responding to them.

While many companies routinely conduct risk assessments, the focus has predominantly been on compliance thus far. To ascertain their efficacy, companies should evaluate whether their teams observe a reduction in process-related or quality-related deviations. Additionally, they should assess the extent to which issues such as recalls, product issues, and customer complaints are decreasing. If the outcomes do not show improvement year after year, strategic adjustments to the quality risk management program are necessary. For Regulatory Response

Shoring up Supply Chains Regulatory response

The enduring repercussions of the pandemic, coupled with the potential for future global health crises, underscore the importance of ensuring convenient access to vaccines and medications. Additionally, disruptions caused by conflicts in Ukraine and Israel, along with increasing economic uncertainty, emphasize the vulnerability of the supply chain, particularly when critical sources are
distant and contingency plans are inadequate.

To mitigate risks associated with the supply chain, especially in specialized manufacturing where a company’s demand is limited in volume or overall value, collaboration among drug producers may be essential to strengthen supply routes. However, finding a way to collaborate without compromising intellectual property is a crucial consideration. By pooling their demands, these producers can create a compelling case for alternative suppliers to enter the market.

A comprehensive review of existing measures, approached with objectivity, can help identify potential risks,

ESG

Environmental, social, and corporate governance (ESG) has become a key concern across various industries, with the biologics sector grappling with a nuanced relationship with environmental sustainability. The challenge arises from the necessity of maintaining low bioburden or sterile manufacturing, a requirement that currently leans towards the use of single-use consumables to ensure patient safety.

While prioritizing patient safety remains crucial, the pharmaceutical industry must also confront its impact on the environment, specifically in terms of single-use plastics consumption. It is imperative to shift focus from a solely patient-centric perspective to a more comprehensive strategy that safeguards the environment from end to end, avoiding any potential accusations of greenwashing.

Maintaining patient safety is undeniably paramount, influencing contamination control throughout transportation and storage. However, striking a balance is essential to ensure that the measures taken to protect patients do not inadvertently lead to contamination affecting entire communities. Finding this equilibrium is crucial for the biologics industry to align with broader environmental and sustainability goals.

Top of Form

End-to-end quality planning

The increase in biosimilar production, driven by the expiration of patents on established drugs, introduces formal requirements encompassing quality and GxP measures. These elements become integral components of manufacturers’ clinical and commercial strategies for emerging molecules.

To establish a significant presence in new markets, companies must proactively integrate quality into their processes from the outset. Anticipating the ideal commercialization of the final product and maintaining alignment with quality considerations throughout are crucial steps that can expedite market entry. This can be achieved through strategic partnerships, such as collaborations with Marketing Authorization Holders, license holders, and organizations offering strategic and scientific guidance.

Critical considerations include forming partnerships with contract manufacturing organizations (CMOs) possessing both clinical and commercial capabilities. This approach ensures that, during the marketing authorization phase, minimal alterations will be necessary to the manufacturing process, mitigating potential issues related to comparability and stability.

Cultivating future capabilities

The global shortage of skills is conspicuous not only in Life Sciences but also in numerous other sectors. It is incumbent upon both the industry and educational institutions to actively confront the increasing disparities in both capabilities and career perspectives among the upcoming generations of teams, particularly those engaged in scientific disciplines like microbiology.

Professionals who have come of age in the ‘gig economy’ often anticipate moving around to accumulate a diverse range of experiences. However, in fields where skills, experience, and enduring commitment are pivotal for maintaining consistently
high standards in quality and risk management, a mindset inclined towards frequent job changes can present challenges. Substantial expertise is derived from successfully navigating complex projects, allowing team members to identify and preempt future issues. In sectors like cell therapy, where products cannot be sterilized by definition, it is crucial to prevent any contaminants during the manufacturing process. Microbiologists, sterility assurance experts, and biotech personnel specialize in ensuring this, but currently, there is a shortage of these professionals.

Instead of merely escalating salary expectations, the industry should collaborate with educational institutions to foster a deeper understanding of the sector and the compelling opportunities it offers. This approach aims to attract not only enthusiastic scientists but also individuals with lateral thinking capabilities—those who can connect the dots across various functions rather than focusing solely on a singular aspect.

 The sector is in need of individuals who possess a sincere and authentic interest in understanding the workings of contemporary pharmaceuticals, the processes involved in accessing therapies, and the development and manufacturing of these treatments. The key to resolving the challenges lies in confronting the prevailing perception that the pharmaceutical industry is inherently negative.

Global Head of Infrastructure, Data and Non-cleared Margin, ISDA (International Swaps and Derivatives Association)

In 2024, the global derivatives regulatory reporting framework is set to undergo significant updates, with Japan and the EU initiating changes to their reporting rules in April. Subsequently, the UK, Australia, and Singapore are expected to follow suit later in the year.

This series of rule adjustments comes on the heels of the first phase of revisions to the US Commodity Futures Trading Commission’s (CFTC) swap data reporting rules in December 2022. These revisions incorporate globally harmonized critical data elements developed by the Committee on Payments and Market Infrastructures and the International Organization of Securities Commissions. The widespread adoption of these global data standards is anticipated to lay the foundation for a more streamlined and effective reporting framework. This, in turn, will empower regulators to construct a clearer and more consistent overview of derivatives market activity.

However, the implementation of data standards and rule updates alone is insufficient. Once rules undergo amendments, market participants must consistently and uniformly implement them. If each entity independently assesses the rules and develops its own reporting logic, it may lead to further discrepancies in how data is reported. To address this concern, ISDA introduced the Digital
Regulatory Reporting (DRR) initiative, utilizing the Common Domain Model to convert a shared, industry-approved interpretation of the rules into human-readable, machine-executable code. Launched ahead of the CFTC rule changes, the DRR has been adapted throughout 2023 to support the implementation of additional forthcoming rule changes in collaboration with ISDA members.

The DRR marks a significant shift in the implementation of regulations, offering market participants a robust method to minimize inconsistencies and inefficiencies in their reporting to trade repositories. As derivatives reporting takes center stage in 2024, ISDA will continue collaborating with market participants to optimize the advantages of the DRR.