Clinical Trial Import License can be defined as an application requesting a license to allow import or manufacturing of any products for the sole purpose of clinical trials. If you’re also looking to manufacture products for clinical trial purposes, then this article will be a treat for you.

Before developing new medicine and marketing it to the public, it’s compulsory to seek a clinical trials license. In these trials, the efficacy, side effects, and quality of medicine are assessed to check whether it is safe to market.

Though the products manufactured to be used in clinical trials don’t have to be registered by NPRA for this, still, it’s very crucial to understand the regulatory framework and monitoring protocols concerning the rules of NPRA clinical trials.

NPRA, or National Pharmaceutical Regulatory Agency, is a Malaysian Ministry of Health governance body that regulates clinical trials and is responsible for issuing Clinical Trial Import Licenses in Malaysia.

How NPRA Defines Clinical Trials

Clinical Trials are a process to determine the effectiveness and dangers of new medicines and other related medical practices for targeted patients.

The clinical trials are divided into four different clinical phases. 

Phase I

Phase I includes trials to assess the safety and effects of the medicines on body systems.

Phase II

The main focus of phase II is on classifying the additional effect of drugs on the tested patients themselves.

Phase III

Phase III trials are performed with the same intent as phase II but are conducted on larger populations.

Phase IV

Phase IV clinical trials are more like assessing the safety of marketed treatment practices and include post-marketing studies.

How to Cover These Phases

Before you apply to seek a clinical trial license for your products in Malaysia, there are some bases you need to cover.

The ministries of health and NPRA have created strict rules to ensure a proper check and balance for allowing clinical trials in Malaysia. You can’t just import a product or manufacture one and start its clinical trial.

You have to follow every single phase but first, apply for a clinical trial license from NPRA. NPRA sets some mandatory protocols that you have to follow to get a clinical trial import license in Malaysia.

If you don’t follow these different protocols, then you will not be considered eligible to conduct clinical trials for any drugs or medicines. If you also wish to conduct clinical trials and are looking for some information, don’t worry. In this article, we’ll discuss all the information related to clinical trials license in Malaysia.

So if you are unaware of the guidelines regarding clinical trials set forth by NPRA, then don’t worry; Victory Pharma Consultancy has got you covered.

Why Choose Victory Pharma Consultancy

Victory Pharma Consultancy has been working for a long time, helping pharmaceutical and biotechnology firms through the very complicated rules and challenges they face in seeking import licenses for medical devices.

We’ll provide you complete support and pilot your business seamlessly through the complex clinical trial import license process.

What You Need to Know

1. What is CTIL?

2. What are the types of products that require CTIL?

∘ A product including placebo that is not registered with the Drug Control Authority (DCA) and intended to be imported for clinical trial purpose

∘ A product with a marketing authorization when used/formulated/packaged in a way different from the approved form; AND when used for unapproved indication to gain further information about an approved use for clinical trial purpose

∘ A traditional product with a marketing authorization with an indication for “traditionally used” when used for unapproved indication/therapeutic claims for clinical trial purpose

∘ An unregistered product, including placebo manufactured locally for clinical trial purpose

3. What are First-in-Human (FIH) clinical trials?

∘ They refer to trials when a new active substance under development is administered to a human for the first time. For FIH clinical trials, only an investigational product (IP) involving a new chemical entity/herbal/natural product with therapeutic claims will be accepted.

∘ Testing for these categories of products will NOT be considered as FIH clinical trials: (1) Generic product; (2) Registered traditional (herbal) product with an indication for “traditionally used” when being tested for therapeutic claims.

4. What is the pre-requisite to applying for CTIL?

For all clinical trials that require CTIL, they must first be registered with the National Medical Research Register (NMRR). Failing to do so will result in the non-acceptance of the CTIL/CTX application.

5. Who can apply for CTIL?

An investigator, who is a person responsible for the conduct of the clinical trial at a trial site can apply for CTIL, as well as an authorized person from a locally registered pharmaceutical company/sponsor/CRO with a permanent address in Malaysia.

6. How long does it take for the application to be reviewed and the license issued?