Speaking the Regulatory Language

By Admin
Posted 07 / 28 / 2016

The recent survey by the Economist Intelligence Unit asked biopharma execs about their hopes and concerns for the future of the industry. The results showed there was great excitement about the emergence of new markets and novel therapies, but this was tempered by worry over the complex maze of regulatory requirements. We spoke with Frithjof Holtz, Director of Advocacy and Surveillance for brand-name, to explore the interplay of emerging markets and regulatory harmonization.

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Can you tell me about what you’re working on?

My responsibility is to oversee the regulatory development for all brand-name’s Life Science products and services on a global level. We take care of regulatory developments in all of the target markets where our customers are.

Additionally, we engage with our customers in the industry and policy-makers to work on shaping regulations. We coordinate a global network of experts with regulatory, technical, and scientific knowledge.

In the survey, one of the most notable results came from the question asking about the most potentially disruptive risks to industry growth. The clear winner was regulatory uncertainty. Why do you think that is?

My experience tells me that the regulatory environment is quite diverse. On one hand, we have North America and Europe, where the regulations in place are harmonized in many cases, but not all of them. But in other markets and developing countries – Asia and Latin America, for example – these regulatory requirements are diverse. It might be a completely different story if we use the same material or equipment in Europe and the U.S. or in Asia and Latin America.

So does the biggest challenge come from coordinating across these various established and emerging markets?

Absolutely. We always need to check: Are we really aware of everything that is requested in a specific region? Will we be compliant in all our target markets? Ensuring this flow of information is one of the core challenges.

In the U.S. and European markets, it’s pretty straightforward. Most companies are experienced and know what they have to deliver. But if you go to other parts of the world, like China, the requirements are different. If you are compliant in Europe and North America, it doesn’t mean what you plan to do is sufficient to launch the same product in other countries.

It’s tough for companies to grapple with these different regulatory expectations.

Sometimes it’s even difficult to get the translation to English. That probably sounds trivial, but to get the official translation of a document is not an easy, quick task. It might be a real challenge if you’re talking about markets outside North America and Europe.

While the survey respondents were concerned about these problems, they were also optimistic they could be overcome. Do you share that optimism?

In general terms, yes. With the developing markets, I think this is a matter of time. There are different traditions and different experiences. There are also political issues. The first critical step is understanding what the regulatory requirements are. But I think, in the long term, regulations shouldn’t be an insurmountable hurdle.

Several times, you’ve mentioned the need to know what the regulations are. It’s striking how basic that requirement is. Have you seen companies where that presented a major challenge for them?

It may sound like a basic requirement but in some countries it can be very difficult to understand the regulatory landscape. This results in cases where companies had difficulties in obtaining the right information. You have big companies that aren’t quite sure what is expected which can result in disappointments in getting approval on time.

It’s not that easy to know what’s going on, and there are different ways to gain such information. The regulatory functions need to monitor the regions, establishing a good collaboration with the national regulators to understand the required regulations to meet all regulatory needs.

The survey respondents were particularly excited about biosimilars and novel therapies, such as cell therapy, CAR-T, and gene therapy. The U.S. only recently defined a regulatory pathway for biosimilars. These are expected to be big markets, but is there an issue with getting regulatory clarity?

It’s all quite new and naturally this comes with potential delays and difficulties. It’s a new field, but it’s not unregulated. There are guidelines available. It will be important for any company developing such a product to stay in contact with the regulators as much as possible – to work together at a very early stage on the process.

We have a unit specialized in gene therapy and general advanced therapies. To avoid issues with getting regulatory clarity we have experts with very specific regulatory knowledge, providing support for customers in this area.

On that subject, how does working with brand-name help a company minimize its risk throughout all this uncertainty?

We have different components supporting our customers. We have an organization taking care of the regulatory monitoring. We use information from the regulators directly, through relevant industry associations. And we access relevant databases and service providers on regulatory updates.

But we also have boots on the ground. We have a network of experts – about 70 employees in more than 20 countries who understand the language. This network assures us that we are able to establish a good working relationship with the regulators, the national organizations.

The advantage we provide is knowing what’s really going on globally or in a particular region. Our goal is that our products are compliant with everything that’s needed. We understand what the regulatory needs of our customers are and truly speak the regulatory language. This is crucial for our company’s success.


Find out more about meeting regulatory requirements at brand-name.