Previously, drug substance manufacturers submitting applications for new drugs, generic drugs, or minor variations involving the introduction or change of a drug substance (DS) manufacturer were not required to provide GMP evidence. However, starting from October 1st, it is essential to note that GMP compliance evidence will be mandatory for these submissions in Singapore. This regulatory change aligns the quality requirements for drug substance manufacturers with those for drug product manufacturers, ensuring a consistent standard of quality across the industry.

Required Evidence for GMP Compliance

To comply with the updated regulations, drug substance manufacturers must submit the following acceptable forms of GMP compliance evidence:

1. GMP Certificate: Issued by PIC/S (Pharmaceutical Inspection Co-operation Scheme) member authorities for the specific drug substance.
2. GMP Inspection Report: This report must detail the GMP inspection, including the drug substance of interest, along with a close-out letter from PIC/S authorities that do not issue certificates.
3. API Registration Certificate: This certificate confirms that the Active Pharmaceutical Ingredient (API) is listed on EudraGMDP (European Database on Good Manufacturing Practices).
4. Certificate of a Pharmaceutical Product (CPP): This must be issued by the US FDA for the API.
5. Manufacturing License: A license from a PIC/S authority covering the drug substance of interest.

Implications of the New Requirement

As these new regulations take effect, there will be several implications for products already registered in Singapore or those planning to submit applications:

• For new drug and new generic drug applications scheduled for submission in Q3-Q4, manufacturers will need to reassess their compliance with the new requirements.
• Existing products that involve a change of manufacturing site will require a reassessment of the supplier’s conformity to the GMP standards mandated in Singapore, which may impact the overall product lifecycle.

Important points to note:

• Products that were approved or submitted before October 1st will not be affected by this new requirement.
• DS manufacturer who has a valid CEP issued for their DS complying to the monograph of European Pharmacopeia , the submission of the GMP evidence is optional.

Ensuring GMP compliance is more than just a regulatory obligation; it represents a commitment to quality and patient safety. By preparing the necessary documentation and adhering to GMP standards, manufacturers can streamline their approval processes and enhance their credibility within the industry.

If you require assistance in evaluating your dossier prior to submission or have any questions regarding GMP compliance, please don’t hesitate to reach out. We are here to help you navigate these requirements effectively.

 

Product Registrant Responsibilities
In Singapore, the Marketing Authorization Holder (MAH), also known as the Product Registrant, is responsible for ensuring that products released into the market are safe and of high quality. This obligation includes pharmacovigilance (PV) activities such as monitoring safety profiles, adverse event reporting, active surveillance programs, and compiling Periodic Benefit-Risk Evaluation Reports (PBRER).

Key Pharmacovigilance Activities

1. Monitoring Safety Profiles: Detecting and evaluating signals from product usage.
2. Adverse Event Reporting: Documenting and reporting any adverse reactions associated with product use.
3. Active Surveillance Program: Proactively monitoring products in the market.
4. Periodic Benefit-Risk Evaluation Reports (PBRER): Regularly assessing the benefit-risk profile of products.

Product Defect Reporting Process

Classification of Product Defects
Product complaints, also known as product defect reports, are classified into two categories:

1. Critical Defects:
   • Pose a serious threat to user or public health.
   • May lead to severe injury or death.
   • Must be reported within 48 hours, excluding weekends.
2. Non-Critical Defects:
   • Do not pose a critical threat but may affect treatment outcomes or product quality.
   • Must be reported within 15 calendar days.

Reporting Requirements
All product defect reports must be submitted through the online form provided by the regulatory authority (link). The initial report should contain comprehensive information, including:

1. Product details.
2. Description of the defect.
3. Affected batch numbers and quantity.
4. Date of occurrence.
5. Expiry date of affected batches.
6. Date of last distribution.
7. Details of the reporter.

An investigational report and Corrective and Preventive Actions (CAPA) plan must follow the initial report, submitted within one month.

Post-Reporting Actions

Based on the initial and investigational reports, the following actions may be taken:

1. Product Recall:
   • Removing defective products from the market.
   • Notification of the recall must be sent to the authority within 24 hours.
2. Dear Purchaser Letter (DPL):
   • Informing purchasers about administrative or logistical details of the recall.
3. Dear Healthcare Professional Letter (DHCPL):
   • Notifying healthcare professionals about significant safety, quality, or efficacy issues.
4. Press Release:
   • Issued if necessary to inform the public.
5. Suspension or Cancellation of Product Registration:
   • May occur if the defect is severe enough to warrant market removal.

Final Reporting
Companies must keep the regulatory authority informed throughout the recall process and submit a product recall completion form along with a reconciliation report to close the incident.

This overview provides a structured approach to handling product defect reporting in Singapore, ensuring that all necessary steps are followed to maintain public health and safety.

For more information: refer to :

 Product Defect Reporting Guideline

Feel free to share with your peers and if you need ad-hoc support in PV front, get in touch!

In the wake of the COVID-19 pandemic, telehealth has become a transformative approach in healthcare, offering patients and providers new ways to connect and deliver care remotely. Initially, telehealth, also known as telemedicine, was primarily used for reviewing stable conditions that did not require physical examinations, such as mental health issues. It has since evolved to include treatment for a wide range of non-emergency medical conditions with mild to moderate symptoms, including common colds, flu, fever, sore throats, rashes, and follow-ups for chronic conditions like hypertension, high cholesterol, diabetes, and gout.

Navigating the regulatory landscape for telehealth services is straightforward in Singapore, thanks to clear and comprehensive guidelines. In this guide, we’ll break down the key regulations you need to know, covering everything from licensing and data protection to professional standards, reimbursement, and technology.

Licensing and Registration

According to the Ministry of Health (MOH), only direct doctor- or dentist-led teleconsultations are licensable under the Healthcare Services Act (HCSA). This is part of the MOH’s risk-based approach to regulating healthcare services. Other types of telehealth, like telecollaboration or administrative support, do not require a licence. Providers, whether they’re individual doctors or dentists, or organisations employing them, need to register for an Outpatient Medical or Dental Service licence and get approval for remote service delivery. It’s a good idea to consult with regulatory affairs services to ensure you meet all the requirements and are properly registered for telehealth services.

Data Protection and Privacy

Protecting patient data is crucial in telehealth, and Singapore has strict laws to ensure this. The Personal Data Protection Act (PDPA) governs how healthcare providers should handle patient information to keep it confidential and secure during telehealth consultations. Providers are required to implement robust measures to safeguard personal health data from unauthorised access and breaches. A confidentiality policy that adheres to relevant legislation, such as the PDPA and the SMC Ethical Code and Guidelines, must be in place to safeguard patient information and records.

Professional Standards and Guidelines

Telehealth professional standards are established to make sure that remote healthcare services meet high-quality benchmarks. In Singapore, telehealth is regulated through several key codes, guidelines, and regulations, including:

• National Telemedicine Guidelines
• Singapore Medical Council’s Ethical Code and Ethical Guidelines, and the Handbook on Medical Ethics
• Regulatory Guidelines for Telehealth Products by the Singapore Health Sciences Authority (Medical Devices Branch)
• Health Products (Licensing of Retail Pharmacies) Regulations and Telepharmacy Guidelines
• Singapore Dental Council’s Ethical Code and Ethical Guidelines

These regulations cover telehealth products, such as software and mobile apps, and focus on the conduct and competency required of healthcare professionals. Adhering to these standards helps maintain the integrity and effectiveness of these services, ensuring they are delivered with the same care and professionalism as in-person consultations.

Reimbursement and Insurance Coverage

It is important for both providers and patients to understand the reimbursement policies and insurance coverage for telehealth services. The rules for reimbursing telehealth consultations can differ from those for traditional in-person visits. Providers need to be aware of how insurance covers telehealth and confirm that their services qualify for reimbursement under current policies. This helps avoid unexpected costs and allows patients to benefit from the coverage available.

Technology and Infrastructure

The success of telehealth services heavily depends on having appropriate technology and infrastructure. Singapore’s regulatory framework specifies the tech requirements needed for effective telehealth, such as secure communication platforms and reliable connectivity. Providers need to invest in and maintain the technology that supports smooth and secure telehealth consultations. This means making sure their systems meet regulatory standards and are capable of handling the demands of remote healthcare.

Navigating Singapore’s telehealth regulations involves understanding several key areas we’ve covered. Adhering to the regulations helps healthcare providers deliver telehealth services that are secure, effective, and legally compliant. If you’re entering the telehealth space or need help with regulatory compliance, consider reaching out to The Reg Consultants. Our team offers comprehensive regulatory affairs services to support your telehealth initiatives.

Contact us today to learn more!

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!