1. I understand that there is no need to apply for both CTA and CTN. If we already have or going to apply for CTA, we dont need CTN.
2. Related to #1. Even if we are using locally sourced unmodified product for approved indication as comparator, there is no need to apply CTN as this information will be included in CTA application form if we have unregistered IMP?
3. What about locally sourced unmodified product for approved indication which is used as auxiliary med for eg. SOC or background med therapies like chemotherapies. Diff sites/institutions may use different brands of chemos as per local SOC/policy. Do we need to collect these information to be submitted for CTN/CTA(if study involved unregistered IMP) application?
4. Now that NPRA will review ICF amendment as well, are we expected to submit for all languages like how we are going to submit to EC? And do we need NPRA approval to implement the updated ICF. I understand that for protocol amendment yes.
5. Now that protocol amendment will require submission and approval, not only notification - may I please ask what is the approval turnaround time? In EC, there is a clear cut meeting dates to refer to.
6. Will NPRA consider to disclose meeting dates (including initial application) to the public so that we can better plan for our submission timeline?

A detail guideline on the import of radiotracer is required, especially we are seeing an increase of oncology trials using radiotracers.

Reliance: This is indeed a good step and making Malaysia a better place for clinical trial. May I check if a study is relied on the approval from other authority e.g., US FDA or Taiwan FDA, can the applicant waive from filing up the application forms? For Reliance evaluation, does this need to go though the meeting? otherwise, the timeline may be extended.

Below are my questions or suggestions:
1. Notification of status of clinical trial reverts back to 6 monthly instead of annual reporting? Why we need a more frequent reporting to authority since annual reporting is considered robust?
2. CTN: Is this applicable to the locally sourced registered IMP?
3. Since payment is implemented for CTA and CTN, can we expect an accelerated approval timeline to ensure Malaysia remains competitive comparing with other countries like Taiwan and Australia? Currently HA approval is the step limiting factor to delay the startup timeline.
4. A clear guidance on how to handle the situation when a locally sourced register IMP uses in an unapproved indication in Malaysia.
5. PI declaration form: are we allowed to collect via eSign? If yes, suggest to only restrict to 1 signature instead of 4 signatures.
6. Manufacturing address: can we provide flexibility in printing the manufacturing address? instead of using the address listed in the GMP certificate?

Summary of comments

Definitions (pp. 4–5)
Key terms such as investigational product and normal clinical practice should be explicitly defined using ICH-GCP E6(R2) standards to avoid subjective interpretation. “Observational trial” should use the term clinical study for consistency, and “qualified practitioner” should be defined. Each definition should cite its source (e.g., ICH-GCP E6 section 1.12) for transparency.

R4 – Sponsor (p. 6)
Requiring a locally incorporated sponsor or Malaysian address may hinder multi-country studies. NPRA should clarify acceptable co-sponsorship or local-representative models and protect local PIs, since ultimate responsibility rests with the sponsor. The phrase “may delegate functions” should specify who may be delegated, qualification criteria, and oversight expectations.

R5 – PI (p. 7)
PIs in clinical trials should hold valid GCP certification, not merely “follow GCP.”

R7 – Registered products (pp. 9–10)
Clarify whether off-label use of registered products requires a CTA, CTN, or other license.

R11 – Serious breach & urgent safety measures (p. 15)
Define “urgent safety measure” and align it with EU/ICH usage—actions to remove imminent hazards. Include a flowchart showing roles, timelines, and reporting routes to NPRA and IRB.

R12 – Status reports (p. 16)
Six-monthly reporting may be excessive. Recommend annual reports, with ad-hoc updates for significant safety or operational changes. Clarify: (1) who submits (sponsor vs PI); (2) whether a single consolidated report suffices; and (3) how NPRA enforces compliance and handles non-submission.

R18 – Protocol amendments (p. 22)
Amended protocols should take effect only after IRB approval, unless needed to remove immediate risk. Define “substantial amendment” and clarify when NPRA re-notification is required.

R21–R23 – Consent (pp. 25–27)
Consent cannot be waived; it must be obtained from a legally acceptable representative (LAR) when the subject lacks capacity. When capacity returns, renewed consent is mandatory. Reformat R22 for clarity. In R23, clarify NPRA vs IRB roles in consent-form approval and amendment notification. Define impartial witness and LAR; revise the final statement so consent complies with—not overrides—national laws.

R26–R30 – Safety reporting (pp. 30–34)
Define USM, AE, SAE, SUSAR, and clarify that NPRA reporting applies only to CTA/CTN trials.

R33–R34 – Products (pp. 37–38)
Define auxiliary product. Provide a mechanism for post-trial or compassionate use to avoid destruction of valuable investigational stock; integrate this into the CTA/CTN process while preventing over-regulation that limits patient access.

R43 – Recruitment (p. 47)
Clarify whether “authorised or accepted by the Authority” refers to trial conduct or advertising approval. Specify the NPRA process for recruitment materials.

R51 – Reliance (p. 56)
Identify recognised reference authorities (e.g., FDA, EMA, MHRA, HSA, TGA), criteria for applying reliance, and its interaction with NPRA review timelines.

R54 – Offences (p. 59)
Current examples misstate requirements as offences. Replace with explicit acts of non-compliance:
– Conducting a trial without NPRA or IRB approval;
– Failure to report SAE/SUSAR on time;
– Submitting falsified data.
Also clarify who “Authority” refers to (NPRA).