The case for best-in-class regulatory controls in pharma – by Rocky Lu

Regulation is sometimes seen as a burden, but not so in the pharmaceutical sector argues Rocky Lu, where it is needed to make sure products are safe and effective.

In an industry where the stakes are high, ensuring the safety and efficacy of pharmaceutical products is crucial. With recent high-profile recalls, safety lapses, and an ever-growing global demand for medicines and healthcare products, the need for stringent regulatory controls in the pharmaceuticals sector has never been more apparent.

As such, best-in-class regulatory controls must be implemented to safeguard public health and reinforce trust in the industry.

The health products and supplements industry has experienced exponential growth in recent years, fueled by a heightened awareness of health and wellness among consumers.

This burgeoning market, however, has also exposed the need for robust regulatory controls to ensure that the products sold are safe, effective, and accurately labeled.

With a diverse range of dietary supplements, vitamins, and herbal remedies available, strong regulation is critical to prevent potential health risks and protect consumers from misleading claims.

In Australia, the Therapeutic Goods Administration (TGA) is responsible for regulating the safety, quality, and efficacy of all vitamins and supplements, playing a pivotal role in protecting public health.

It is crucial for the TGA and other regulatory bodies worldwide to collaborate and continuously update their policies and practices to keep pace with the rapidly changing pharmaceutical landscape.

One major reason for the need for strong regulatory controls is the rising issue of counterfeit and substandard medicines and health products.

The World Health Organization estimates that one in ten medical products in low- and middle-income countries is substandard or falsified.

Such products not only pose significant health risks to patients but also undermine the credibility of the pharmaceuticals sector as a whole.

By implementing best-in-class regulatory controls, authorities can better detect and prevent the distribution of these dangerous products.

Another compelling argument for stronger regulatory oversight is the need for transparency and accountability in clinical trials.

In recent years, there have been numerous instances where pharmaceutical companies have been found to conceal or manipulate clinical trial data.

By establishing more rigorous reporting standards and demanding greater transparency from manufacturers, regulatory agencies like the TGA can ensure that clinical trials are conducted ethically and that the data they produce is reliable and accurate.

The need for strong regulation also extends to the accurate labeling of health products and supplements. Consumers must have access to clear and reliable information about the ingredients and potential side effects of the products they purchase.

Strict regulatory controls can ensure that manufacturers provide comprehensive and transparent labeling, enabling consumers to make informed decisions about their health and wellbeing.

The global nature of the pharmaceutical industry also necessitates international cooperation and harmonisation of regulatory practices.

The COVID-19 pandemic has highlighted the importance of a coordinated global response to public health crises, and this is equally applicable to the regulation of pharmaceuticals. By working together to establish common standards and best practices, regulatory authorities can more effectively address cross-border challenges and promote global health.

Australia has demonstrated its commitment to international cooperation through its involvement in the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), which aims to coordinate inspection procedures and standards for good manufacturing practices.

Participation in PIC/S ensures that the TGA and other regulatory bodies maintain consistently high standards for the manufacture of pharmaceutical products, ultimately safeguarding public health on a global scale.

Critics may argue that tighter regulations could stifle innovation and slow the approval of new products.

However, this argument overlooks the fact that public trust is a key factor in the success of the pharmaceuticals sector.

By demonstrating a commitment to quality and safety, regulatory agencies can help to restore and maintain this trust, ultimately benefiting both patients and industry stakeholders.

The case for best-in-class regulatory controls in the pharmaceuticals sector is clear.

By strengthening oversight, increasing transparency, fostering international cooperation, and leveraging technology, regulatory agencies can ensure that only safe and effective medicines reach the market. Quality is not just a lofty ideal in the pharmaceuticals sector—it is a moral and ethical imperative.

Rocky Lu, is the General Manager of GMP Pharmaceuticals Girraween Site. He has a USYD Master of Chemical Engineering and specialises in softgel, tablet, hardshell, liquid, powder, sachet manufacturing. Founded in 1994, GMP Pharmaceuticals has been a market leader in health supplement manufacturing for over 25 years, offering services including product formulation, label design, packaging solutions, shipping and regulatory advice.

Picture: Rocky Lu