Why Brazil Pharmaceutical Companies Should Consider Expanding Their Pharmaceutical Portfolios in Singapore and Other ASEAN Countries


Brazil pharmaceutical companies offer a diverse and innovative portfolio of products. However, due to geographical distance, most companies focus on developing their market within Brazil and the U.S. There are many compelling reasons for Brazilian companies to consider expanding into Singapore and other ASEAN countries, where they can leverage strategic regulatory advantages and market opportunities that support efficient entry and growth.

Regulatory Synergies: Singapore and Brazil

One of the key regulatory advantages for Brazilian companies looking to enter the ASEAN market is that Brazil’s health regulatory authority, ANVISA, is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Many ASEAN countries, including Singapore, require PIC/S GMP compliance, allowing Brazilian companies to bypass additional inspections during the registration process. This waiver can significantly reduce lead times in regulatory approval, giving Brazilian companies a quicker route to market.

Climate Compatibility: Shared Zone IVb Stability Requirements

A unique advantage Brazil holds is its geographic location in Zone IVb, which aligns with ASEAN’s required climatic stability conditions for pharmaceutical products. This means that Brazilian companies can use existing stability studies, avoiding the need for additional testing specific to the ASEAN region. This shared climatic zone can result in considerable cost savings on stability studies and compliance, giving Brazilian products a competitive edge in terms of time and expense.

Comparing Regulatory Processes: Brazil vs. Singapore for Generic and New Drug Registration

While there are similarities, it’s essential for Brazilian companies to understand the regulatory differences between Brazil and Singapore, especially regarding generic and new drug registration. Below are key considerations that companies should factor into their ASEAN market expansion strategy.

  1. Registration Pathways

In both Brazil and Singapore, the registration pathway differs significantly for new drugs versus generics. For instance:

New Drugs: In Singapore, Health Sciences Authority (HSA) offers a structured pathway for innovative and new drugs, which may include priority review  if the drug is deemed essential and lacks alternatives. In contrast, ANVISA in Brazil also has a pathway for new drugs, though companies may face longer timelines due to a multi-stage evaluation process.

Generics: The process for registering generics tends to be faster in both Brazil and Singapore, but while ANVISA requires proof of bioequivalence and local testing, HSA may accept certain international data, reducing redundancy and potentially expediting registration for companies with existing global dossiers.

  1. Evaluation Timelines

Evaluation timelines vary widely:

In Brazil, ANVISA’s timelines can range from six months to two years depending on factors such as product type and completeness of the initial submission. Backlogs can also affect timelines, particularly for new drug applications.

HSA is known for shorter timelines, often ranging from nine to eighteen months for both new drugs and generics, especially for applications that meet international standards and are well-documented. Singapore also offers prioritized processing for essential medications, which may benefit companies with innovative therapies.

  1. Documentary Requirements: Common Technical Document (CTD)

Both Singapore and Brazil use the CTD format, but specific requirements within the document vary, particularly for Modules 2-5:

Module 2 (Quality Summary): In Singapore,  HSA requires a comprehensive QoS which may differ from ANVISA’s requirements.

Modules 3 to 5: For new drugs, Brazil and Singapore both demand comprehensive preclinical and clinical data, but Singapore may accept foreign clinical trial data if it’s from recognized health authorities, whereas ANVISA may require supplementary data to align with Brazilian standards.

  1. Stability and Climatic Zone Requirements

Given the shared Zone IVb classification between Brazil and ASEAN countries, Brazilian companies can often use existing stability studies for Singapore, eliminating the need for additional stability testing. This alignment is particularly advantageous for generics, as it simplifies compliance with local stability requirements in Singapore.

  1. Labeling and Language Requirements

Singapore mandates labeling in English, and specific products may require simplified language for consumer understanding. Brazil similarly requires Portuguese labeling for domestic sales.

 

Making Expansion Decisions Easier: A Simple Regulatory Checklist

For Brazilian companies considering expansion into the ASEAN market, the following checklist can support a preliminary regulatory assessment, helping to identify both potential hurdles and advantages:

  • Registration Pathway: Assess whether the registration pathway aligns with your product type, as requirements may differ significantly between new drugs and generics.
  • Evaluation Timeline: Consider the estimated evaluation timeline for product approval, which can vary based on the specific ASEAN regulatory authority’s processes and the complexity of the product type.
  • Technical Dossier Requirements (M2-M5): Review the dossier sections required for submission in ASEAN, particularly Modules 2 to 5 of the Common Technical Document (CTD). This assessment should take into account if the product is a new drug or a generic, as requirements may differ.
  • Labeling Requirements: Ensure compliance with ASEAN-specific labeling requirements, which often include language adaptations and specific formatting to meet local standards.

By considering these key points, companies can conduct initial regulatory intelligence to streamline the expansion process. If your company is ready to enter the ASEAN market, The Reg Consultants (TRC) is available to provide expert regulatory support, helping you navigate these requirements with ease.

Feel free to check out other relevant articles:

https://theregconsultants.com/overcoming-the-challenges-of-registration-of-a-generic-drug-in-singapore/

https://theregconsultants.com/why-is-regulatory-intelligence-exercise-crucial-for-pharma-companies-looking-to-expand-into-new-territories/

https://theregconsultants.com/why-is-regulatory-intelligence-exercise-crucial-for-pharma-companies-looking-to-expand-into-new-territories/

https://theregconsultants.com/5-self-check-questions-for-pharma-market-access-in-singapore/

 

 

  • Share This Article:

Hand picking pharmaceutical product for regulatory consulting in pharma

If you have any specific regulatory questions pertaining to entering the Singapore market or require assistance with pharma regulatory services and medical product registration, feel free to reach out. Your success in the pharmaceutical industry starts with us!

We use cookies to ensure you get the best experience on our website.