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

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 Its unfamiliarity with local regulatory guidelines may cause it to work with outdated, incorrect information.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

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

Comprehensive Compliance Suppor

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

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?

Clinical Practices

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?

The Safety and Quality of CPM 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!