Express Medication Registration: Reducing Digemid’s Control
- LIMA,Peru (AP) — In a move intended to streamline access to medications,particularly for rare diseases and cancer treatment,the Peruvian Congress approved a law on April 3 allowing expedited...
- However, the legislation has sparked debate and apprehension among healthcare professionals and patient advocacy groups, primarily due to its potential impact on the quality control processes overseen by...
- The new law mandates a maximum 45-day evaluation period for DIGEMID to process sanitary registration applications.
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Peru Approves Expedited Review for Foreign-Registered Medicines,Raising Concerns
Table of Contents
- Peru Approves Expedited Review for Foreign-Registered Medicines,Raising Concerns
- Peru Approves Expedited Review for Foreign-Registered Medicines: what You Need to Know
- What is the New Peruvian Law Regarding Medicine Approval?
- How Does the Expedited review Process Work?
- What are the Main Concerns About This New Law?
- Why is the 45-Day Review Period Considered Insufficient?
- What are the Potential Risks Associated with This Law?
- Who Benefits From This Law?
- Has the Executive branch Addressed the Concerns?
- What are the Key Provisions of the Law?
- Summarizing the Key Provisions of the New Law
LIMA,Peru (AP) — In a move intended to streamline access to medications,particularly for rare diseases and cancer treatment,the Peruvian Congress approved a law on April 3 allowing expedited review of medicines and biological products already registered in countries with stringent health oversight. The law passed with 63 votes in favor, 19 against, and 11 abstentions.
However, the legislation has sparked debate and apprehension among healthcare professionals and patient advocacy groups, primarily due to its potential impact on the quality control processes overseen by the General directorate of Medicines, Supplies and Drugs (DIGEMID), the Peruvian regulatory agency.
Concerns Over Expedited Approval Process
The new law mandates a maximum 45-day evaluation period for DIGEMID to process sanitary registration applications. Failure to meet this deadline results in automatic approval. Critics argue this timeframe is insufficient for thorough evaluation, perhaps weakening DIGEMID’s ability to prevent substandard or counterfeit medications from entering the Peruvian market.
The Pharmaceutical Chemical College of Peru, the Medical College of Peru, and various patient organizations have voiced concerns that a uniform 45-day review period fails to account for the varying complexities of different medications, including generic, biological, and biosimilar drugs. Each requires a distinct and rigorous evaluation process tailored to the specific disease or condition it aims to treat.
Historical Context and Potential Risks
Concerns are rooted in past experiences. In the 1990s, a policy of automatic authorization led to the influx of uncontrolled medicines, endangering public health. Evidence of this could be seen in places like Capon Center in Lima, where medications of dubious origin where sold.
Executive Branch Inaction
Adding to the controversy, the Executive branch has been criticized for failing to regulate Article 9 of Law No. 29698, which prioritizes the treatment of rare or orphaned diseases. Regulation would have facilitated access to these medications, addressing evaluation and financing, instead of focusing on the current project proposed by Congressman Ernesto Bustamante. A decree (Supreme Decree No. 002-2025-SA) regulated the rest of the law a few days prior.
Key Provisions of the Law
The approved law stipulates that biological medicines and products authorized in countries with high health surveillance will undergo evaluation within 45 days. Automatic approval
Peru Approves Expedited Review for Foreign-Registered Medicines: what You Need to Know
This article provides a comprehensive overview of the new Peruvian law allowing expedited review of medicines, addressing its key aspects and the concerns it raises.
What is the New Peruvian Law Regarding Medicine Approval?
The Peruvian congress approved a law on April 3rd that allows for expedited review of medicines and biological products already registered in countries with stringent health oversight. The aim is to streamline access to medications, particularly those for rare diseases and cancer treatment.
How Does the Expedited review Process Work?
The new law mandates that the General Directorate of Medicines, Supplies, and Drugs (DIGEMID), the Peruvian regulatory agency, must process sanitary registration applications within a maximum timeframe of 45 days. If DIGEMID fails to meet this deadline, automatic approval is granted.
What are the Main Concerns About This New Law?
The primary concerns revolve around the potential impact on quality control. Critics fear that a 45-day evaluation period might be insufficient for thoroughly evaluating the safety and efficacy of all medications, potentially allowing substandard or counterfeit medications into the Peruvian market. These concerns are primarily voiced by:
- The Pharmaceutical Chemical College of Peru
- The Medical College of Peru
- Various patient organizations
Why is the 45-Day Review Period Considered Insufficient?
One major criticism is that a uniform 45-day review period doesn’t account for the varying complexities of different types of medications.The evaluation process required for generic drugs, biological medicines, and biosimilars can be highly complex necessitating more time for thorough evaluation.
What are the Potential Risks Associated with This Law?
The concern over the law stems from past experiences. The 1990s saw a policy of automatic authorization that led to an influx of uncontrolled medicines, endangering public health.Evidence of this event coudl be seen in places like capon Center in Lima, where untrustworthy medications were sold.
Who Benefits From This Law?
the law aims to benefit patients, especially those with rare diseases and cancer, by streamlining their access to treatments. This could potentially reduce waiting times and increase the availability of life-saving medications.
Has the Executive branch Addressed the Concerns?
The Executive branch has been criticized for failing to regulate Article 9 of Law no. 29698, which prioritizes treatment for rare or orphaned diseases. Regulation of this article woudl have supported access to these medications, addressing evaluation and financing.Rather, the focus has been on a project proposed by Congressman Ernesto Bustamante. A decree regulated the rest of the law just prior.
What are the Key Provisions of the Law?
the law stipulates that biological medicines and products authorized in countries with stringent health surveillance will undergo evaluation within 45 days. Automatic approval is granted if the deadline is not met.
Summarizing the Key Provisions of the New Law
Here’s a summary table outlining the key points of the new Peruvian law:
| Aspect | Details |
|---|---|
| Objective | Streamline access to medications, particularly for rare diseases and cancer treatment. |
| Review Period | maximum 45 days for sanitary registration applications. |
| Automatic Approval | Granted if DIGEMID fails to meet the 45-day deadline. |
| Medicines Covered | Medicines and biological products already registered in countries with high health surveillance. |