Big Pharma: The Time is Right for Mexico

A previously sluggish economy is regaining pace quickly, and a recent change of government has meant considerable funding being channelled into the Ministry of Health. Because of this Dr. Llopiz-Aviles believes that the time is right for pharmaceutical manufacturers to invest in Mexico.



Dr. Marlene Llopiz-Aviles is President of the Association of Medical Specialists in the Pharmaceutical Industry (AMEIFAC) and the Secretary-General of the International Federation of Associations of Pharmaceutical Physicians (IFAPP), as well as Chairperson for the Mexican Chapter of the Association of Clinical Research Physicians (ACRP). Dr. Llopiz-Aviles shares her key pieces of advice for pharmaceutical companies who are considering market access in Mexico.

Recent changes might not have necessarily made it easy for manufacturers looking to enter Mexico, but the changes have provided much-needed structure to the procedure. Dr. Llopiz-Aviles states that, “regulatory affairs for market access have become more professional and stricter, and this guarantees a lot more for pharma. It is a safer and accessible marketplace for them. More diverse kinds of drugs which affect qualified patents on existing drugs will not get into the country. Recent certification from the Pan American Health Organisation (PAHO) has placed the Mexican Ministry of Health in a similar status to the EMA and the FDA. The regulatory issues have not become easier, but they are not impossible to meet. They are just stricter - and stricter means better in my eyes.”

Take time to engage your regulators

The key for pharmaceutical manufacturers is to know exactly what you need from regulators, advises Dr. Llopiz- Aviles. Everyone who approaches the market jumps through the exact same hoops. However, it is very important to take the time to understand what the role is of each professional involved in the process, cautions Dr. Llopiz-Aviles. “A lot of the time pharma can expect someone from the regulators to do something, when this responsibility is actually someone else’s within the regulatory task-force or even pharma´s, these sort of things can get lost in the translation.”

The key for manufacturers who are focusing on Mexico from abroad is to approach the Ministry of Health in the manner that you want to do things clearly and by the book. It is important to make sure it is clearly understood who is going to take responsibility for what, what the associated timelines are with each deliverable and what your limitations are in terms of budget. Dr. Llopiz-Aviles states, “If this process is crystal clear to both parties then gaining access to the Mexican market is straightforward. The key challenge is mainly within setting down the rules for getting started on the processes.” While Dr. Llopiz-Aviles notes that these processes are slow, this is the product of an ethos of guaranteeing quality through quality evaluation procedures.

While the government is encouraging investment in healthcare, it is equally important that products are manufactured in the correct way and do not have active principles which are inadequate. The government wants to make sure that only drugs which are good for the country and that are good for their patients are going to make it through the regulatory process. This requires strict procedures which are time intensive; however, if you have the correct certification and follow the proper procedures, no obstacles should come in the way of moving forward.

The key takeaways for overcoming the regulatory hurdle:

  1. Understand how to approach and who to approach within the Ministry of Health
  2. A face to face meeting with the Ministry of Health is essential
  3. Make sure to set out clear timelines and responsibilities
  4. Partial dossiers will slow down submission – ensure you provide all documentation together

I would always approach the Ministry of Health first. It is very important to secure a face-to-face meeting in order to open the door and directly ask for advice.

Dr. Llopiz-Aviles states that the commissioners within the Ministry of Health are extremely open to discussion before starting the regulatory process and recommends that foreign companies approaching the market make sure to take advantage of this. It is simple to engage the commissioner directly and clearly map out how you need to proceed step by step. While there are companies who offer this service to manufacturers entering the market, Dr. Llopiz-Aviles cautions that it is important to make sure that you are getting the right advice, or you risk slowing down the approval procedure. Dr. Llopiz- Aviles says, “I would always approach the Ministry of Health first. It is very important to secure a face-to-face meeting in order to open the door and directly ask for advice. While the Ministry of Health have set down very strict regulatory rules, they are extremely open to a personal approach.

Dr. Llopiz-Aviles notes that this is actually a very recent change in culture. Several years ago the ministry used to be extremely closed off and it was very hard to even get a meeting. However, recently this is something that has very much changed.  Dr. Llopiz-Aviles says, “The regulators are very open and happy to set up discussions and this is extremely good. They have a much younger crowd of officials and executives within the Ministry of Health who have a very different perspective on how things should be done. While procedures are rigorous and they have set a strict tone, they are very open to engagement.”

Although much has been done to professionalise the regulatory procedures, Dr. Llopiz-Aviles offers one final piece of advice and recommends manufacturers to maintain a degree of flexibility with timelines for deliverables.. Dr. Llopiz-Aviles says, “It is a team effort, it is not just down to the government officials, make sure to focus on building a cordial relationship where you both work together.”


Dr. Llopiz- Aviles will be joining a panel discussion on engaging stakeholders to gain market access at the 4thannual eyeforpharma Market Access Mexico congress this week. For the full roadmap on how to succeed with market access in Mexico, make sure that you join over 300 of your peers. Don't miss out, find out more here.