Developing a new drug or pharmaceutical product for the market can be a tortuous process. From the earliest pre-clinical trials to final marketing approvals, a rigorous set of criteria must be met if a product is to proceed to the point at which it can improve the treatment of patients.

The world has certainly begun to sit up and take notice of regulatory issues in the pharmaceutical industry, and the extent to which they could be a help or hindrance in the speedy delivery of safe, effective medicines to patients around the world. The announcement of President Obama’s 2012 budget proposals in February made provision for a 33% increase to the FDA’s funding to a total of $4.3bn. The budget proposals also took potentially controversial steps to encourage the manufacture of
cheaper generic drugs in order to reduce costs for patients.

This is just one set of ideas to improve the regulation of pharmaceutical products for the benefit of patients. Many, for example, claim that Obama’s encouragement of generic biologics will further reduce the incentive for big pharma to carry out original research for new medicines – essential research that governments cannot afford to do themselves.

One concept on which everyone can agree is the value of creating a more unified approach to regulating pharmaceutical products, as well as building some intelligence into the development and manufacturing process to minimise waste and improve safety. Organisations are working hard to untangle regulatory systems to simplify the delivery of new drugs to the patients that need them.

“Organisations are working hard to untangle regulatory systems to simplify the delivery of new drugs to the patients that need them.”

Harmonisation: unravelling the regulatory web

The global regulatory system for pharmaceutical products is incredibly complex, with different national and international agencies establishing different (and sometimes contradictory) standards and best practices.

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By GlobalData

The Food and Drug Administration (FDA) and the European Medicines Agency (EMA), the agencies responsible for regulating new medicines in the US and Europe respectively, have different criteria that drug developers must meet, requiring separate applications and validations. Even
within the EMA, different national agencies, such as the Medicines and Healthcare products Regulatory Agency (MHRA), provide another layer of complexity.

For Peter Gough, a partner at pharmaceutical consultancy and training firm NSF-DBA who has also served on EFPIA committees, the pace and complexity of regulatory change is startling. “It’s quite a challenge just trying to keep up with what’s going on, and that’s why these days the job involves searching the internet and using personal contacts with people who are involved with some of the changes across the industry. But it’s quite a challenge to keep up, particularly with the EU at the
moment, which really seems to be churning stuff out.”

The fragmented nature of pharmaceutical regulation continues to be an obstacle to the efficiency and harmony of worldwide drug development; efforts are being made to create a more unified system. The EU and the US are taking steps to forge a closer bond in the future to reduce the disparity between the two systems. Much of this change is being spearheaded by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (thankfully
shortened to ICH), which is organising collaboration between regulatory authorities all over the world, particularly between principal partners the EU, the US and Japan.

Globalising the ICH ideal

Japan has experienced particular delays (up to four years in some cases) in approving products that are already available in the US and Europe, and in 2007 it was noted that only 28 of the 88 most popular medicines in those regions were available to Japanese patients. The head of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) Akira Miyajima has stated the organisation’s intention to reduce approval times by two and a half years and bring the Japanese drug approvals system
into line with the US and EU by 2012. “The potential benefits of this exercise are expected to include accelerated access of patients to new and innovative medicines; resource savings due to reduced duplication of assessment and improved performance and safety,” said Miyajima in a letter to the EMA.

“Japan has experienced particular delays in approving products that are already available in the US and Europe.”

Gough agrees that important steps have been taken, especially through the work of the ICH, but says that formidable challenges mean that global harmonisation is still just a blip on the horizon. “First of all, there’s a significant challenge to get the EU to harmonise, within itself,” he says. “Secondly, even if we could get the ideal of a more harmonised approach with the ICH partners, there’s the rest of the world to become involved. Will they accept the need for it? I was talking to a
colleague in South Africa and saying that some of these concepts are going to be completely alien to regulators in the South African authorities, for instance. And what about the Brazilians, the Indians and the Chinese? The Chinese are still trying to get the basics of GMP [good manufacturing practice] right.

“If a manufacturing site has got a process that’s been designed for quality by design, it might have design spaces or real-time release built into it; is that going to be acceptable to the authorities in Korea, for instance? We’re getting to the point where it’s becoming acceptable for the FDA and the EU, and in theory Japan as they’re part of the ICH. But it’s the globalisation of the concept that’s going to be the challenge, I think.”

Quality by design: a blueprint for the future?

Quality by design (QBD), a manufacturing concept stating that quality assurance should be built into the manufacturing process from the earliest stages, has been a key talking point for the ICH in recent years as something that should be applied to the drug development and manufacturing process. It’s an idea that relies on fluent communication between the manufacturing and clinical ends of a pharmaceutical business and sophisticated tools to synchronise validation and risk management during
all stages of development, approval and commercial manufacturing.

“We’ve still got outdated concepts like validation being an event that you go through somewhere between development and commercial operations, and that’s it,” explains Gough. “The whole QBD concept is that you start with the end in mind; you design both your product and the production process to produce your product in a coherent way. You understand all of the variables and the interactions between variables, and develop a design space for your process that you operate in. And that carries
on through into the commercial phase.”

“A more efficient and integrated development and manufacturing process could accelerate the approval process.”

A more efficient and integrated development and manufacturing process could dramatically reduce wasted costs and accelerate the approval process, but is it the place of regulatory agencies to insist on such fundamental changes to the industry’s business model? “That’s a very interesting question,” says Gough.

“It’s not technically their place. Rather than the regulators insisting on the more advanced things in ICH Q8, 9 and 10 they ought to insist that you understand your production processes and that you track them in real-time using things like control charts and process capability to make sure that nothing changes. I think that’s the aim of the new FDA Process Validation Guidance.”

The requirements of pharmaceutical regulators are incredibly important – robust regulation is vital to ensure that drugs are as effective as they claim to be and pose no unknown dangers to the public. But the regulatory regime is beginning to ask itself if the disparate nature of its agencies and the industry’s outdated processes are suitable for this task. And this can only be a good thing for patients.