Author: Wanda Dobrzanski M.D, Head of Clinical Operations Latin America, Medpace
On April 26th, The Ministry of Health in Argentina (ANMAT) issued a new regulation that significantly reduces the timelines for the approval of clinical trials (Provision Nº 4008-2017 (in Spanish – with option to translate to English.) This modifies the Provision Nº 6677/10 which rules clinical research in Argentina). The new regulation will accelerate the evaluation process from 160 business days to 70 days or less. With this revised legislation in place, Argentina is expecting to double the trials running in the country in the next 24 months according to Argentina’s president, Mauricio Macri. In fact, there are already strong signs regarding the impact of this new regulation that were shared by the Argentinean Chamber of Pharmaceutical Products (CAEMe: Camara Argentina de Especialidades Medicinales) which stated that 20 studies were approved during a recent two week time period.
Key Changes:
- Establishes a “validation period” of 3 working days (start counting the day after the submission). Only complete packages will move forward to the evaluation process
- Evaluation process is expected to take 60 working days (for technical evaluation) + 10 working days (for administrative aspects): 70 working days in total for Clinical research studies
- Studies evaluated and approved/ongoing in countries with high vigilance standards will be approved in 45 working days (to provide technical reports) + 10 administrative working days (to issue final approval letter): 55 days in total
Note: Countries listed in Annex I mentioned in the regulation are: United States, Japan, Sweden, Switzerland, Israel, Canada, Austria, Germany, France, UK, The Netherlands, Belgium, Denmark, Spain and Italy.
In addition, Provision 4009/2017 was passed with these key changes:
- Establishes requirements for approving Principal Investigator to be involved in Bioequivalence/Bioavailability Studies; and Special conditions needed in Healthcare Centers in order to conduct Phase I Clinical and Bioequivalence Studies, (regarding building conditions, infrastructure, medical services and technical condition)
- Authorizations for the facilities for Phase I will have a validity of 5 (five) years
Our Take
This is significant news for any Sponsors looking to conduct clinical trials in Latin America with Argentina being one of the key countries. We believe these new regulations and the resulting shorter timelines for evaluations make Argentina an attractive country for running clinical trials. There are a number of advantages including:
- A high concentration of potential trial subjects
- Qualified and reliable medical professionals
- Low drop-out rates
- Strong enrollment and compliance rates with low drop-out rates
- Quality data with excellent performance in all FDA & EMA audits
You can learn more in this webinar presentation – Latin America: Challenges and Opportunities in Clinical Research.
Argentina is ripe for clinical research. I’m happy to discuss your upcoming research needs and how Argentina and Latin America can fit in.
Regards, Dr. Wanda Dobrzanski