In a tough regulatory climate being forewarned is forearmed, says ISI Europe

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Related tags: Management

Don’t think of the global regulatory information clampdown as a burden. It’s an opportunity to put your house in order, says Adam Sherlock, MD of ISI Europe.

Globally, regulatory authorities are clamping down on the way pharma companies record and manage key information across the product lifecycle. Yet this is no bad thing, as it forces them to sharpen their internal practices, creating new opportunities for efficiency and innovation, while reducing their exposure to commercial risk.

Tighter regulatory information management offers enormous potential to help companies make strategic commercial decisions around their entire portfolio of products, and thus be more competitive.More fundamentally, however, robust regulatory IM is an essential element in product registrations, and in communicating with regulators. Discrepancies and data errors could delay or derail the submission process.

As international pharmaceutical organisations target ever more markets, the levels of complexity multiply, heightening the need for more sophisticated regulatory IM solutions.

Beyond the initial licence

Even when a product is in commercial supply, timely and accurate information reporting can be crucial. In the event of a safety issue, companies that can quickly respond will be in a better position to avert a crisis or limit any damage. For this reason, a comprehensive regulatory IM strategy should incorporate submission management, registration management, portfolio management and resource planning. Yet many organisations tend to let things slide beyond the initial drug application or marketing authorisation application (MAA), neglecting licence maintenance.

To be truly effective and efficient, the goal must be holistic information management, and the ability to release and share required content readily. All too often, companies are unable to promptly access the specific data they need, the consequences of which can be highly costly – resulting in marketing licenses being pulled from a given country, or huge product recalls due to a failure to adequately trace problems.

By deploying a fully functioning regulatory IM solution, companies are able to keep tabs on all of the components in the manufacturing cycle—including where ingredients come from—in a systematic way, through a centralised system. Once the source of a problem has been identified, the organisation is able to establish where tainted ingredients have ended up, and simply pull the affected products from the market rather than be forced to conduct a global product recall. More importantly, they are able to reduce the potential risk to patients.

Other potential benefits include the ability to perform predictive sampling and analysis, and to track chemistry, manufacturing and control.

In an aggressively competitive and global market, finely tuned processes are vital to long-term success and sustained growth. The risks of regulatory IM avoidance, by contrast, are extremely high. As a minimum, organisations run risk of falling foul of increasingly strict authority standards, then becoming mired in red tape and potential loss of business as they strive to put things right. In the worst case scenario, they could be putting lives at risk.

Those organisations that are able to put a positive spin on regulatory IM projects stand to benefit the most from new administrative initiatives. Those who do the bare minimum risk losing more than they gain.

Related topics: Markets & Regulations, Globalization

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