Pharma Distribution: Top Tips for Meeting Regulatory Approval in the Middle East

In this interview Hassan Bibi, Regional Regulatory Affairs Director NEWAAT - Janssen Pharmaceutical companies of Johnson and Johnson, talks about overcoming the 3 main challenges with regards to meeting regulatory approval and improving distribution operations across the Middle East.

What would you say are the three main challenges with regards to meeting regulatory approval and approving distribution operations across the Middle East? H Bibi: Limiting this to three main challenges is not really something that we can agree on. There are lots of challenges in this part of the world because of the regulations in the countries where we are trying very hard with the health care professionals and even the authorities responsible to make it the best.

The other challenge that we can talk about is the complexity of the product manufacturing process that we are also facing nowadays. And I believe this is something that’s a big challenge, not for J&J only but for all companies. And if we can look at the third challenge, it’s mainly the requirements posted by the local country regulations versus the EU regulations that most of our product complexity manufacturing processes are not really taking into consideration, the requirements in the country.

So we can say in summary it’s the regulation by itself in the countries, for registering a product, the complexity of the product manufacturing and the requirement in the countries versus EU and international regulations. Those are the three main challenges in meeting regulatory approval.

What recent trends have you witnessed in the last three to five years? H Bibi: This is really a very good question. I would like to share with you what I really witnessed the last three to five years about the changes of regulations and registration requirements in the country; the continued requirements of these regulations. What I notice is that whenever we have a new regulation - a couple of months or a year we have something new, I cannot say that this is negative or positive. But this is something that we really witnessed the last couple of years.

The other issue that I would like to mention, again, is the complexity of the product manufacturer. Maybe these products or the new products are for really very important diseases and it’s not really straightforward manufacturing of these products. And this is why maybe we have lots of biological products that make the manufacture, the supply, the releasing of the product not easy.

The other thing that I would like to mention, the price, price differences and the increases in the price that we are facing, maybe because of the economic crisis that we are facing so far at this time. And the trend of the dual and triple sourcing of the same product, which is not, unfortunately, in line with the current regulation in some countries within the region. But this is something that we should look at and we should really take it into consideration because the demand on the product is not really being just focused on one site or one source. So this is why maybe the trend of dual and triple sourcing are becoming really a mandatory thing that should be taken and should be done for these innovative products.

What would be your top tips for meeting regulatory approval? H Bibi: For me the regulatory approval is a matter of technical, physical, scientific approach that we should really have aligned together, definitely the importance of the product, the need of the product in the market. Plus all the technical and scientific documentation that should be really available and in line with the country regulation. This is definitely not limited to the product supply and the production of the product itself. These are the top tips that I would like to share because this will really put you in a position where you can really meet regulatory approval.

Definitely we have lots of challenges when submitting the product and reviewing the product and achieving the registration but this is everywhere. To have it ready you must be really ready from different perspectives, from scientific, technical, physical and different, let’s say requirements where you can really reach an approval for this product.

What measures have been taken to reduce counterfeiting in the pharmaceutical supply chain? H Bibi: In fact there are a lot of measures that have been taken to reduce counterfeiting and to make it happen needs a lot of effort and lots of work between different stake holders. I believe this is everybody’s responsibility, which mainly involves the ministry of health, pharmaceutical companies, customs, pharmacies, patients and other health care professionals. Most of all we have lots of awareness and education programs that are coming through as everybody’s concern. We try to adapt some reporting systems based on the needs in every country to really help to give information regarding any counterfeit or possible counterfeited products. We work together; we have different health care professionals, governmental officials, nongovernmental officials, to educate everyone on the risk and the seriousness of the counterfeit products. How they harm the patients from any safety concern. Definitely we try to continue the awareness vis a vis different associations and try to be there in every forum, to really have people to identify the counterfeits.

It’s also a collaboration between the customs, between different ministries, between the pharmacists, the patients and everybody. So we try to establish some, let’s say some systems, whether a hologram on the pack or whether by automatic SMS systems where the patients can reach the company and tell them whether this product is counterfeit, fake or original. So we’ve really developed a lot of programmes and we try to take any possible way to reduce the counterfeiting.

And how are regulatory authorities, the pharmaceutical industry working together in the Middle East to develop legislation and regulatory practices? Does it enable patients to have access to good quality medicines including innovative medicines?

Hassan Bibi: In this part of shaping the regulatory legislation and practices we as the pharmaceutical industry try and work together with different authorities in order to help them shape the legislation. The main objective is to have good quality medicines, including the innovative ones, in the market. We work together via different occasions and via different associations, whether it is governmental officials or nongovernmental officials to educate everyone on the importance of developing legislation to meet product availability in the market. And most of all to have quality medicine availability in the market.

We have a type of association which is a pharma association where a regulatory group of different pharmaceutical companies try to sit together and meet with the authorities and officials. And also meet with our partners who are the importers because the importers also have their own committees. We do a lot of collaboration in order to help to shape the legislation and regulatory practice. These types of groups work together hand in hand with the regulators and the authorities in order to see what can be done to reduce the extra, let’s say requirements, that may not be of any benefit, neither for the patients nor for the product and even not for the authorities. So we have this type of awareness and education training that takes place from time to time in different countries, which mainly focuses on educating and helping our regulatory authority representatives to shape the way of doing the job. To know more about international regulations, to even educate them on some EU legislation, maybe some country’s practice, on some counterfeits. Some training related to quality and many other topics that mainly also comes from the authority’s concern. So the regulatory authorities come to us with subjects of concern and of interest and we try to help them to be focused, mainly using this type of information.

We have a lot of examples that took place in the region. We had a special regulatory day with authorities in Lebanon in the last two years. We continue to really work hand in hand with the regulatory authorities in different countries, to sit together and try to do the best for our patients. And most importantly to have access to good quality medicines including innovative medicines.