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Pharmacovigilance - Product Registration Holders

1. Is the local Pharmacovigilance (PV) responsible person/ QPPV required to be based in Malaysia?

The QPPV is preferably to be based in Malaysia. However, in the event where the main QPPV with medical knowledge is based outside Malaysia (e.g. Singapore), the NPRA would require a contact person to be based in Malaysia. The contact person must be contactable by the NPRA at all times and the Malaysian contact person may then consult the QPPV for any issues pertaining to PV. The details of both the contact person and the main QPPV must be informed to the NPRA.

2. “ The Authority will maintain strict confidentiality with regards to the identity of patients and reporter”. Is there any guidance on the implication of the Personal Data Protection Act 2010? Since PV reporting is non-commercial data collection, is it not mandatory to have informed consent from the reporter?

Referring to Section 40 (1)(b)(i) Personal Data Protection Act 2010, “The processing of sensitive personal data is necessary for the purposes of exercising or performing any right or obligation which is conferred or imposed by law on the data user in connection with employment.” (Sales of Drugs Act 1952, Control of Drugs and Cosmetics Regulations 1984, Regulation 28)

Hence, it is not mandatory for PRH to have informed consent from the reporter.

3. What are the ADR reporting requirements to the Authority for the following scenarios: a) Country of Adverse Event (AE) occurrence is Malaysia but the medicinal products is not from Malaysia. (e.g. the patient bought the product overseas). b) Country of AE occurrence is Malaysia but the medicinal products is not registered in Malaysia. For e.g. medicinal products under exemption use/ compassionate use.

a) This ADR is not mandatory to be reported as the medicinal product is not registered in Malaysia. However, the NPRA would encourage the reporting of this ADR as it occurred in Malaysia.

b) You may report this ADR to the Bahagian Perkhidmatan Farmasi (BPF), of which the contact details are stated in the approval letter for exemption use/compassionate use. A copy of the report is required to be sent to the NPRA.

4. In a scenario of cumulative cases which involved non-specific patient numbers, e.g. Reporter shared that 2 – 3 of his patients experienced diarrhoea after taking product A, OR Reporter commented that a few of his patients experienced bleeding after taking product B. Is this reportable?

Each ADR report should involve only one patient to fulfill the validity of an ADR report (identifiable reporter, patient, ADR and drug). Therefore, for the scenarios mentioned above, separate reports need to be submitted for each patient involved.

5. What is expected from the statement in P3.6.1.3: Information on Suspected Adverse Drug Reaction (ADR) from the Mass Media, Internet or Digital media: “Product Registration Holder (PRH) should regularly screen mass media, internet or digital media for potential reports of suspected ADR.”

The PRH-sponsored websites/programs in mass media, internet or digital media should be screened regularly, while non-PRH-sponsored websites/programs should be included in the screening process once it has come to the knowledge of the PRH that the websites/programs are related to the PRH’s registered product. The company is free to determine the screening procedure.

6. With regards to P3.6.2.1 Compassionate use/ Named patient use. “The protocol should encourage the prescriber to report any adverse reactions suspected of being related to use of the medicinal product to the Authority.” a) Who holds the ultimate responsibility of ADR reporting under compassionate use/named patient use? b) Can the protocol be exempted for “named patient use” requested by one doctor for one patient OR a request that is initiated by hospital on regular and larger quantity basis?

a) The prescriber is ultimately responsible for the ADR reporting under compassionate use/named patient use because the approval of use is granted to the prescriber. However, if the ADR has come to the knowledge of the PRH and the ADR has not yet been reported to the Authority, then the PRH holds the responsibility to report to the Authority.

b) The protocol is not exempted for the given situations.

7. Are the following ADRs reportable to the Authority? (a) all serious expected and unexpected ADRs, including unusual failure in efficacy for new drugs in organized data collection system described in P3.6.2 (Solicited Reports). (b) all serious expected and unexpected ADRs, including unusual failure in efficacy for new drugs in studies subject to post-market ADR reporting requirements (e.g. phase IV studies)

(a) Yes, they should be reported to the NPRA, especially those which occurred in Malaysia.

(b) Yes, the PRH should only report the ADRs detected in local studies to the NPRA.

8. With regards to P3.9.1.1 Pregnancy. “If a PRH becomes aware of a signal of possible teratogenic effect (e.g a cluster of similar abnormal outcomes), the Authority should be informed in writing immediately .” Please clarify whether the timeframe is no later than 3 calendar days or within 24 hours.

The acceptable timeframe is within 24hours. The Authority should be informed immediately, as the possible teratogenic effect is a cluster type and the urgency of reporting cannot be ruled out.

9. With regards to P3.10 Summary Reports. Are the PRH required to prepare summary reports annually or only when requested by the Authority?

The summary report is to be prepared only upon request by the Authority.

10. With regards to P3.11 Adverse Drug Reactions occurring outside Malaysia. “Information on Withdrawal/ Suspension of the registration status in any country should be notified to the Authority within 24 hours of first knowledge by the PRH.” Please clarify is the withdrawal / suspension of the registration status due to emerging safety issues only. If the withdrawal of registration status is due to business decision, can it be exempted?

P3.11 should be applied to those withdrawal/suspension of the registration status due to emerging safety issues only. However, if the withdrawal is due to business decision that will eventually affect Malaysia’s registration status, you should notify the Authority within 24 hours of first knowledge.

11. Does NPRA accept EU Risk Management Plan (RMP)/Japanese RMP/US REMs? Or the RMP should be in a local format?

At the moment, there is no specific Malaysian format for RMP, though the NPRA plans to develop this in the near future. The format included in the current Malaysian PV Guidelines is adopted from the EU RMP format.

The EU RMP format is preferred for submission, although the Japanese RMP/US REMs are also accepted for the time being. However, the PRH should then explain in the RMP submission cover letter the applicability of the RMP/PV activities to Malaysia as well as the justification if the pharmacovigilance plan or risk minimisation measures are not to be implemented locally.

12. If local information is required in RMP, please specify which section would require localised information?

For the time being, we do not specify any particular sections which require localised information, unless otherwise required due to safety issues. If local information (e.g. epidemiological data) is available, it should preferably be submitted/ used, as it allows a more practical design of RMP to be implemented in Malaysia.

13. Would there be any requirements to conduct any local studies? If yes, please advise under what circumstances? Also, please advise if this will be a pre-requisite to approval of the product?

Yes, there may be requirements to conduct local studies. The requirements to conduct local studies are usually made on a case-to-case basis, or depending on the safety issues which arise. If a local study is required, it might be part of the registration condition.

14. What are the consequence(s) of non-compliance to the guideline?

This guidance document is issued by the Director of Pharmaceutical Services under Regulation 29, Control of Drugs and Cosmetics Regulations 1984. Therefore, any non-compliance to the guidance is considered an offence.

15. Would there be any presentation or seminar to summarise about the new guideline?

At the moment there will be no presentation or seminar to summarise about the new guideline as a pre-launch dialogue has been done in June 2015 with the pharmaceutical industry. We will update the frequently asked questions (FAQ) related to the PV Guidelines on the NPRA website from time to time.