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.
- 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.
- 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.
- 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.
- 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.
- 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/5-self-check-questions-for-pharma-market-access-in-singapore/
In recent times, we’ve received numerous inquiries about the possibility of rebranding complementary health and cosmetic products in Singapore, particularly due to geopolitical factors. Many companies are looking to facilitate export to their home countries, and understanding how to rebrand products as “Made in Singapore” can be a strategic advantage. In this article, we’ll explore what constitutes a product as “Made in Singapore,” the pathway to achieve this , and the certifications available from Singapore Customs , Singapore Manufacturing Federation, as well as the Singapore International Chamber of Commerce, that can facilitate export.
What is Considered a “Made in Singapore” Product?
A “Made in Singapore” product refers to goods that are substantially manufactured or processed within Singapore, in line with regulatory criteria established by local authorities. To earn this designation, a significant portion of the production costs—including labor and materials—must be incurred locally, ensuring considerable local value addition. Furthermore, products must comply with Singapore’s safety, health, and environmental standards to meet quality expectations.
It’s essential to note that if a product is manufactured outside of Singapore and only undergoes labeling or assembly here, it may be labeled as “Packed in Singapore” or “Secondary assembled by ABC Pte Ltd in Singapore.” However, it cannot be marketed as “Made in Singapore,” as this designation necessitates significant manufacturing or processing within the country.
Importance of Free Sale Certificate (FSC) and Certificate of Origin (COO)
When exporting goods, obtaining a Free Sale Certificate (FSC) and a Certificate of Origin (COO) can significantly streamline the process and enhance market acceptance in your destination country.
- Free Sale Certificate (FSC): Issued by Singapore Customs, the FSC confirms that the products are sold locally in Singapore and are compliant with local regulations. It serves as a testament to the product’s quality and safety, making it easier for foreign authorities to accept the product without extensive scrutiny.
- Certificate of Origin (COO): This document attests to the origin of the goods and is essential for international trade. Many countries require proof of origin to determine applicable tariffs and compliance with trade agreements. There are two types of COOs:
- Ordinary COO (Non-Preferential): Identifies the origin of the good but does not allow overseas buyers to claim preferential tariff treatment, as it is not issued under any Free Trade Agreement.
- Preferential COO: Enables your buyer to benefit from lower or no customs duty when exporting under a Free Trade Agreement or Schemes of Preferences.
Steps to Brand Your Complementary Health Products or Cosmetics as “Made in Singapore”
- Set Up a Manufacturing Facility: Establish a manufacturing facility that adheres to Good Manufacturing Practice (GMP) requirements to produce your product, or partner with a licensed contract manufacturing facility that specializes in complementary health products. Ensure that your facility is registered with relevant authorities to facilitate inspections and audits.
- Ensure Regulatory Compliance: Comply with the relevant regulatory controls for your type of health product. Prepare comprehensive documentation to establish the quality, safety, and efficacy of your product. This documentation should include:
- Product specifications
- Safety data sheets
- Clinical studies (if applicable)
- Quality assurance protocols
Seek the appropriate approvals before marketing and distributing it locally. This may involve obtaining licenses to import and distribute if necessary.
- Obtain Necessary Certifications: Once you receive approval from the regulatory authority, you can apply for a Free Sale Certificate from Singapore Customs or a Certificate of Origin from the Singapore Manufacturing Federation and the Singapore International Chamber of Commerce to facilitate exportation, depending on the domestic procedures of your destination country.
- Free Sale Certificate: To apply for the FSC, submit your application along with supporting documents that demonstrate your product’s compliance with local regulations. The certificate will detail the product’s description, registration numbers, and the local regulatory authority’s confirmation.
- Certificate of Origin: To obtain a COO, you will need to provide documentation that supports the origin of your goods. This may include:
- Invoices
- Shipping documents
- Manufacturing process details
COs are issued by the Singapore International Chamber of Commerce and the Singapore Manufacturing Federation. Ensure that you are familiar with the requirements of the importing country to facilitate a smooth export process.
For further information, please refer to the following resources:
We hope this information proves useful to you. Be sure to check out our other related blogs that may interest you:
- 3 Facts to Know When Importing Cosmetics into Singapore
- Addressing Regulatory Challenges in the Cosmetics and Personal Care Industry in Singapore
- Navigating Nutraceutical Regulations Within the ASEAN Region
- Key Things to Note When Importing Health Supplements into Singapore
Whether it is hardware or software as a service – subscription services are rising to prominence in our daily lives. However, mention our subscription plan for regulatory affairs, and some might be left scratching their heads. While this is an understandable reaction to a layman, our subscription plan can aid businesses in need of regulatory assistance.
In particular, medical companies may find our plan indispensable, given the nature of the industry, where regulations, standards, and best practices continuously evolve, thus necessitating constant vigilance and resources to maintain compliance. For those unaware of its benefits, let us delve into why businesses in the medical industry can benefit from our subscription plan.
Benefit #1: Stay Up-To-Date With The Latest Regulatory Changes
Staying abreast of the various regulatory and guideline changes and updates can be akin to navigating a complex maze, especially if the business operates in a new territory where the best practices differ significantly from its country of origin. Its unfamiliarity with local regulatory guidelines may cause it to work with outdated, incorrect information.
Our subscription plan allows companies to tap on our local expertise as a regulatory service provider to advise on regulatory issues revolving around their business plans and products. Our consultants regularly keep up-to-date on the latest regulatory changes and can provide real-time updates and insights into evolving guidelines pertinent to the industry. This helps businesses to come up with proactive compliance strategies and mitigate the risk of non-compliance penalties and reputational damage.
Benefit #2: Oversee Regulatory Affairs
Effective regulatory compliance requires robust oversight and management. So, beyond staying informed on the newest changes, it is essential for businesses to maintain comprehensive and precise oversight of their regulatory affairs. However, this can be challenging for those unfamiliar with local regulations and guidelines.
As part of the services offered by our subscription plan, our consultants can help manage various aspects of the enterprise’s regulatory affairs. This includes updating operational standard operating procedures (SOPs), conducting training for distributors based on materials prepared by the client, and attending meetings as the company’s regulatory affairs representative. That, in turn, empowers businesses to oversee their regulatory affairs with precision and confidence.
Benefit #3: Comprehensive Compliance Support
With our regulatory affairs subscription plan, businesses can access our comprehensive tools and resources tailored to streamline compliance processes. We can help expedite compliance tasks, fostering operational efficiency and risk mitigation, ensuring companies encounter minimal issues when expanding into a new market.
Benefit #4: Cost-Effective
Our regulatory affairs subscription plan offers a scalable and economical means of achieving compliance excellence, with comprehensive regulatory information and resources readily available. As a result, businesses can eliminate the need for costly in-house expertise and infrastructure.
Instead, by leveraging our local expertise to perform the work on their behalf, enterprises can eliminate the worry of rising costs while redirecting available resources to focus on more crucial objectives, such as growing and expanding the company.
Regulatory affairs management extends beyond product registration and securing the necessary approvals for marketing and distribution. Our subscription plan can help streamline the entire process, providing comprehensive support even after the initial registration stage and allowing businesses to maintain sustainable growth and ethical conduct in today’s regulatory environment. Contact us today if you are interested in learning more about our subscription plan.
Traditional Chinese Medicine (TCM) requires strict regulatory adherence in Singapore, with the practice heavily regulated by the Traditional Chinese Medicine Practitioners Board (TCMPB) under the Ministry of Health (MOH). To practise TCM legally in Singapore, practitioners must be registered with the TCMPB and hold a valid practising certificate.
The stringent scrutiny in terms of licensing, premise requirements, and adherence to good clinical practices also extends to all TCM clinics and healthcare establishments, with the MOH conducting regular inspections and audits to ensure every premise complies with these strict regulations.
In addition, Chinese Proprietary Medicines (CPM) – i.e. medicinal products used according to the traditional Chinese medicine (TCM) system of treatment that are manufactured into finished dosage forms (for example, tablets, capsules, pills) – are governed by The Health Sciences Authority (HSA) and must comply with a set of safety and quality criteria before they are made available to the public in Singapore.
So, as you can see, those wishing to practise TCM or enter the CPM industry must navigate a complex tapestry of requirements to ensure everything is above board and their business complies with regulations set out by Singapore’s health authorities. Therefore, it is unsurprising that many turn to a regulatory affairs service for help. If you are in a similar boat, let us help you better understand the situation by sharing a regulatory overview of TCM in Singapore.
Read More: Navigating Regulatory Changes in Singapore’s Healthcare Industry
How is Traditional Chinese Medicine regulated in Singapore?
Presently, TCM clinics need not register with MOH. However, they are still subjected to scrutiny by MOH to ensure they comply with good clinical practices. Meanwhile, any professional who wishes to practise TCM in Singapore must be registered with the TCMPB and hold a valid practising certificate issued by the Board, which regulates the professional conduct and ethics of registered TCM practitioners.
If you wish to start a TCM practice and want to learn more about the comprehensive regulations, we recommend consulting a regulatory service provider to ensure full compliance.
How is Chinese Proprietary Medicines regulated in Singapore?
To ensure the safety and quality of CPM in Singapore, all local CPM dealers, including importers, manufacturers, re-packers, and wholesalers, must be licensed by HSA. These businesses must also apply for product listing approval for each CPM before importing, manufacturing, or selling the item in Singapore.
Needless to say, the process to get the products successfully listed with HSA is stringent, as dealers must meet relevant safety and quality requirements for their CPM.
The products must not contain:
- Any potent/toxic substances controlled under the Poisons Act
- Any artificial chemical compounds found in Western medicines
- Excessive levels of toxic heavy metals like arsenic, lead, and mercury and microbial contamination
Additionally, all CPM products must have English labels with the following:
- Product Name
- Batch Number
- Expiry Date
- Active ingredients
- Dosage
Dealers are also not allowed to make claims for treating a specified list of severe medication conditions, such as diabetes and cancer, on their product labels. If the business is made aware of an adverse event, it must report the incident to HSA immediately.
After the CPM product is made available to the public, there is a post-market surveillance programme implemented to observe the safety of the medicines.
Monitoring Process
- Firstly, a risk-based market surveillance programme is conducted to sample and test products found in the market.
- Secondly, an adverse reaction surveillance programme draws on HSA’s network of local healthcare professionals and international regulatory partners to identify any medicines that may potentially cause adverse reactions.
This system of checks and controls ensures that HSA is able to initiate timely recalls of harmful or defective products.
If you wish to learn how you can successfully navigate the complex regulatory requirements in the CPM industry, we recommend seeking the advice of an expert regulatory affairs management team.
The TCM regulatory landscape in Singapore underscores the nation’s commitment to professionalism, integrity, and patient safety. Every aspect, from practitioner qualifications to product quality control, is meticulously controlled to uphold standards of excellence and ethical conduct.
However, navigating this labyrinthine landscape need not be complex and confusing when you work with the correct regulatory affairs service. As a regulatory service provider with a wealth of experience assisting local and global pharmaceutical and medical companies, we are well-placed to answer any regulatory query you have about the industry. Contact us to schedule an appointment with our regulatory affairs management team today!