HomeArchive by Category "Regulatory News"

China Releases Guidelines for Preparing Pharmacovigilance Outsourcing Agreement (Interim)

July 13, 2020

4 June 2020, The China National Centre for Adverse Drug Reaction (ADR) Monitoring releases guidelines applicable for drug marketing license holders (hereinafter referred to as “holders”) who carry out pharmacovigilance work.

The aim of the document is to clarify and standardize the responsibilities of the holders and trustees in the commissioning of pharmacovigilance in ensuring identification, monitoring, evaluation and control of post marketing adverse drug reactions and other drug-related harmful reactions.

The guidelines will assist the holders when preparing pharmacovigilance commission agreement.

In the event a trustee is entrusted to carry out pharmacovigilance work, the legal responsibility lies on the borneholder. For example, if the holder is an overseas enterprise, the  trustee entrusted by it within the territory of China shall perform the obligations of the drug marketing license holder and bear joint and several liabilities with the drug marketing license holder.

The scope of the guideline includes preparation of the agreement including pharmacovigilance entrusted matters such as adverse drug reactions and serious adverse drug reactions occurring overseas and the requirements in selecting a trustee.

The holder and the trustee’s relevant person are parties to the agreement and relevant responsible departments participate in the drafting and formulation of the pharmacovigilance commission agreement.

Audit, data, and risk management procedures are also incorporated as requirements in the guideline.
It is provided in the guideline that the holder and the trustee shall establish a good and effective communication mechanism and formulate a communication plan.

Please refer to the link below for further information:-

http://www.cdr-adr.org.cn/drug_1/zcfg_1/zcfg_zdyz/202006/t20200604_47472.html

TGA Publishes Specification on Release of Information on Clinical Trials of Therapeutic Goods

July 10, 2020

On June 2020, The Therapeutic Good Administration (TGA ) of Australia has released The Therapeutic Goods (Clinical Trial Inspections) Specification stipulated under subsection 61(5AB.

Pursuant to  Subsection 61(5AA), the legislation permit the Secretary to release specific details on therapeutic goods on clinical trials involving therapeutic goods(other than medical devices ) to the approving authority and ethics committee.

The authority in the legislation refers to the person or body at whose site where a clinical trial is carried out (or conducted in part, for a clinical trial conducted at more than one site) and governs the trial.

This provision will ensure the safe and lawful conduct of the trial in compliance with good and ethical clinical practice.

Among the details comprised in the specification includes the authority responsible for the documenting the specification, the commencement date, the definition of terms used in the specification and the type of information that is permitted to be released to the category of authorities.

The vital information that may be released is listed in Schedule 1 of the Specification which includes compliance of the trial with the National Statement on Ethical Conduct in Human Research, the Guideline for Good Clinical Practice, and the procedural protocol approved for the trial by the ethics committee.

Further information can be obtained from https://www.tga.gov.au/specifications

Malaysia Issues Guidance Documents on Complaint Handling and Mandatory Problem Reporting for Medical Devices

July 9, 2020

In line with the objective to assist the healthcare professionals in the industry towards compliance with the Medical Device Act (Act 737), the Medical Device Authority (MDA) has issued a guidance document on June 2020.
The document lists the requirements on complaint handling for all medical devices applicable to exporters dealing with medical devices.

A system is put in place to handle complaints from patients, home users, healthcare practitioners, maintenance providers, or the general public. The user of any medical device can submit a  complaint using a standard form to the establishments.

The document also discloses the procedure of receiving and recording complaints.  The complaint should also be assessed to determine if it is a reportable event.  All complaints received shall be recorded and tracked. The complaint is assessed based on the nature of the complaint and deemed as a reportable event.
Further, the Authorised Representative (AR) or manufacturer submits the complaint to the Authority within the specified time. These problems can be reported by submitting a Mandatory Problem Reporting Form and Investigation Form to the Authority.

The root cause of the incident is investigated upon the reporting and a field corrective action is conducted to avoid future recurrence of events.

The investigation will be assessed by the Authority to ascertain if it is satisfactory and they shall determine if the matter can be closed.

The implementation of the Corrective and Preventive Action (CAPA)  is based on the root cause of the complaint.
The annexure of the guidance document contains the process flow for handling medical device complaints and the medical device complaint form.

Kindly refer to the link for the two guidance documents:-

https://portal.mda.gov.my/documents/guidance-documents/1435-complaint-handling-60-60-23jun2020/file.html
https://www.mda.gov.my/documents/guidance-documents/1427-mandatory-problem-reporting-60-60-10-june2020/file.html

NPRA of Malaysia Implements Fast-Track Review for Clinical Trials

July 6, 2020

On 18 June 2020, the National Pharmaceutical Regulatory Division (NPRA) of Malaysia has published a circular announcing a fast-track review for clinical trials applicable for clinical trial import license applications and unauthorized manufacture of unregistered products for clinical trial purposes.

This working procedure was tabled and approved by the Drug Control Authority (DCA) at its 345th meeting.
The criteria for fast-track review include the application of new research products used for treatment/prevention in pandemic/epidemic situations for public health except for the First-in-Human (FIH) study.

The existing application and evaluation procedures remain unchanged except for a shorter application evaluation period than the available procedure.
There are two categories of the product, one being a biological product, Cell & Gene Therapy Products( CGTP), herbal products with therapeutic claims that only require 22 business days as compared to 45 business day within the standard review.

Other products that do not fall in Phase 1 Category require 14 business days under the fast track review as compared to 30 business days within the standard review.

The implementation is effective from 01 April 2020 onward.

For more information, kindly refer to :- https://www.npra.gov.my/index.php/en/component/content/article/40-english/circulars/1527115-pekeliling-berkenaan-pelaksanaan-prosedur-kerja-fast-track.html?Itemid=1391

TGA Waives Pre-Approval for Medicine Advertisements in Specified Media

July 3, 2020

Effective from 1 July 2020, pre-approval from Therapeutic Goods Administration (TGA) is not required for medicine advertisements in selected media.

The advertising of therapeutic goods will still be regulated by  TGA and advertisers shall abide by the requirements of the therapeutics goods legislation which includes the Therapeutic Goods Advertising Code.

The document published by TGA states that advertisers will still require pre-approval for advertisements about medicines in accordance with Therapeutics Goods Regulations 1990. The pre-approval is only needed up to 30 June 2020 for ads published in magazines, newspapers, newsletters, catalogues, cinema advertising, public displays about goods, including posters, billboards, and displays in or on public transport.

Pre-approval is not required effective 01 July 2020 onwards.
The Expert Review of Medicines and Medical Devices Regulations have proposed the change to promote self-regulation by advertisers.

The advertisers will however be required to ensure that the ads meet the requirements as per the advertising code and therapeutic goods legislation .

The self  regulatory approach is supported by a wide range of enforcements especially with the listing of offenses on the TGA website. The information provides a clearer picture of unlawful publication or broadcast of ads related to therapeutic products.

In the event advertisers require guidance on the self-regulatory steps, they may seek advisory services.
The requirement for approval for restricted representation still remains and is unaffected by the new legislation.

Advertisers may seek further information about  the legislation at https://www.tga.gov.au/node/904821

TGA Waives Pre-Approval for Medicine Advertisements in Specified Media

July 1, 2020

Effective from 1 July 2020, pre-approval from Therapeutic Goods Administration (TGA) is not required for medicine advertisements in selected media.

The advertising of therapeutic goods will still be regulated by  TGA and advertisers shall abide by the requirements of the therapeutics goods legislation which includes the Therapeutic Goods Advertising Code.

The document published by TGA states that advertisers will still require pre-approval for advertisements about medicines in accordance with Therapeutics Goods Regulations 1990. The pre-approval is only needed up to 30 June 2020 for ads published in magazines, newspapers, newsletters, catalogues, cinema advertising, public displays about goods, including posters, billboards, and displays in or on public transport. Pre-approval is not required effective 01 July 2020 onwards.

The Expert Review of Medicines and Medical Devices Regulations have proposed the change to promote self-regulation by advertisers.

The advertisers will however be required to ensure that the ads meet the requirements as per the advertising code and therapeutic goods legislation.  The self-regulatory approach is supported by a wide range of enforcements especially with the listing of offenses on the TGA website. The information provides a clearer picture of unlawful publication or broadcast of ads related to therapeutic products.

In the event advertisers require guidance on the self-regulatory steps, they may seek advisory services.
The requirement for approval for restricted representation still remains and is unaffected by the new legislation.

Advertisers may seek further information about  the legislation at https://www.tga.gov.au/node/904821

China to implement new Clinical Drug Quality Control Standards to harmonise GCP standards with ICH standards

June 29, 2020

In order to deepen the reform of the drug review and approval system, encourage innovation, and further promote the research and improvement of the quality of drug clinical trials in China, the State Drug Administration, and the National Health and Health Commission organized and revised the “Clinical Drug Quality Control Standards”, which is released on April 23  2020 and effective from July 1, 2020.

The Chinese standards are essentially a GCP document which has been harmonized with ICH standards.

The document provides clarification of sponsor and investigator reporting responsibilities for clinical safety reports.

 

 

For more information, please refer to: http://www.nmpa.gov.cn/WS04/CL2138/376852.html

NPRA of Malaysia Issues Directive on Pre -Registration Test Results of Natural Products

June 25, 2020

On 12 May 2020. National Pharmaceutical Regulatory Division (NPRA) has issued a directive by the Director of Services Pharmacy pertaining to pre-registration test results of natural products from private laboratories.

Directive  No. 8 of 2020 states that the Director has agreed to the acceptance of pre-registration test results of natural products from private laboratories approved by the National Pharmaceutical Regulatory Division (NPRA) and local manufacturers’ quality control laboratories as per the requirements of  No. (8) BPFK / PPP / 07/25 Jld.4.
All product registration holder is directed to comply with these requirements.

Product Registration Holder (PRH) must submit test results in the form of a certificate of analysis (CoA)
for evaluation purposes through the Quest 3+ system.

There is no need to submit pre-registration samples to the NPRA laboratory.

The directive also includes process work and acceptance criteria for decisions on product testing.
There are no changes to the fees and application period for the evaluation of natural product registration.
The directive has also included the list of NPRA accredited private laboratories on their website.

Local manufacturers may issue a certificate of analysis for their own products.
Imported products must obtain an analytical certificate from NPRA panel laboratories.
The type of tests are required to be carried out are listed in the directive and shall be specified in the analytical certificate.
For further information, please refer to https://www.npra.gov.my/easyarticles/images/users/1048/gambar/DIREKTIF-PENERIMAAN-KEPUTUSAN-PENGUJIAN-PRA-PENDAFTARAN-PRODUK.pdf

Malaysia Issues Directive for Physical Testing for Lot Release Activities for Vaccine and Plasma Products

June 22, 2020

On 12 May 2020,  the National Pharmaceutical Regulatory Division (NPRA) of Malaysia  has announced a directive by the Director of Pharmacy Services pertaining to physical testing for Lot release activities for registered plasma product and each vaccine  imported by Malaysia as per directive Bill(9) BPFK/PPP/07/25 Jid.4.

Pursuant to Directive No. 9 of 2020, physical testing depends on the form of the dosage of the vaccines and plasma products.  For example, appearance test and particulate contamination (visible particles) are to be carried out on parenteral fluid. Appearance, Solubility, and particulate contamination (visible particles) on reconstituted finished product tests are to be carried out on freeze-dried or Iyophilized powder.

The increase in these physical testing requirements has been updated accordingly in the Guidance Document for Biological Product Lot Release in Malaysia.

The directive also states that the registrar shall submit 3 units of the product together with the diluent
(where applicable) for each cluster according to the time period. For instance, in the event the warehouse is located in Klang Valley ,the registrant has to submit the product within one(1) working day upon the cold network inspection.

The NPRA will also issue a  Lot Release certificate on vaccine clusters and plasma products if all four Lot Release requirements (including physical testing) are being complied with. On the contrary, if one of these requirements is not followed, a Notification of Non-Compliance will be issued and the vaccine batch and plasma products involved shall be disposed of in Malaysia.

The document has also indicated that the duration for  Lot Release certificate issuance will still take six (6) working days after the vaccine and plasma products have arrived at the product warehouse.

For more information pertaining to the directive, please refer to  https://www.npra.gov.my/easyarticles/images/users/1048/gambar/DIREKTIF-KEPERLUAN-MENJALANKAN-UJIAN-FIZIKAL.pdf