Regulatory News | Pharma to Market

Malaysia, guidance document for the pre-submission meeting.

April 2, 2020

Malaysia, guidance document for the pre-submission meeting.

On 13th February 2020, the Guidance Document for Pre-Submission Meeting (PSM) was unveiled.

PSM a new service provided by the Nationalized Regulatory Division of Pharmacy. A platform intended for product registration holders to ask questions and seek clarification on product quality, safety and efficacy during the product development stage.

Their current focus is on 4 product categories:

1.      New drug products;
2.      Biologic products (including biosimilar products);
3.      Natural products with therapeutic demands;
4.      Health supplement products with the risk of disease reduction.

Issues related to the application for a manufacturer license or Good Manufacturing Practice (GMP) certification are not covered by the scope of the PSM.

For the start of this new implementation, the total number of meetings will be limited to 1 session per month, a maximum of 2 PSM sessions per product.

Product registration holders interested in getting PSM services can do so by followings the below-mentioned steps:

1. Complete the PSM request form from www.npra.gov.my.

2. Make sure you are a locally incorporated company, corporate or legal entity, with a permanent address and registered with Companies Commission of Malaysia.

3. Ensure PSM request form is emailed at least 8 weeks in advance before the proposed meeting
date to presubmission@npra.gov.my.

4. NPRA will then review and screen the applications.

· If approved, applicants will be notified with the confirmation.
· If not approved, applicants will also be notified and introduced to other alternatives.

Refer to the procedure (Via the link) in the Guidance Document for Pre-Submission Meeting (PSM) guidelines for more information.
https://bit.ly/3aonJ67

The services offered are non-mandatory. However, any advice provided by NPRA during the PSM is non-binding, taking into account the regulatory developments that may change from time to time.

The implementation of this new implementation would officially be on 15th March 2020.

China, NMPA announces the publication of guidance document on medical device registration

March 30, 2020

China, NMPA announces the publication of this guidance document to further strengthen the administration and supervision on medical device registration, as well as to improve the efficiency and quality of administrative procedures.

This guidance establishes requirements for product design and manufacturing, which are defined as “essential principles of safety and performance” and intended to give instructions to medical device manufacturers on product development and manufacturing.

The guidance is structured in two parts:

(Part I) General principles for all medical devices.
(Part II) Specific principles that apply to non-diagnostic devices and in-vitro diagnostic devices (including combination products).

The activities of design and production by manufacturers should be conducted under the control of QMS.

Manufacturers are required to provide justification for compliance with these essential principles, which will then be evaluated by the supervision authority.

Link to source: https://www.cmde.org.cn/CL0058/20607.html

Japan, Updated guidance on biocompatibility testing of medical devices

March 26, 2020

Japan, Updated guidance on biocompatibility testing of medical devices

Updated guidance relating to biocompatibility testing of medical devices was released by The Ministry of Health, Labour and Welfare of Japan in February 2020.

With reference to the updated guidance, all biocompatibility testing must be done in accordance with the requirements provided by standard JIS T 0993-1:2020 which actually constitutes an ISO 10993-1 standard in Japanese.

This new document mainly covers the standards when confirming compliance with biocompatibility requirements for the application of approval for manufacturing or marketing medical devices.

It also details the way biocompatibility testing should be done and the particular testing methods to be applied for the results to be reliable and acceptable for its intended purposes.

Partial implementation of the requirements set forth in ISO 14971, which describes the risk management in regards to medical devices was also done in this new update.

Essential definitions such as Raw materials, The final product, Hazard and Risk were specifically highlighted.

The Japanese authorities cautioned that national and international standards could be subjected to review due to the constant development of science and technologies.

Hence, manufacturers are strongly encouraged to stay updated with the latest standards to implement the most appropriate testing method themselves.

USA, FDA launched Guidance Snapshots

March 23, 2020

A brand pilot program has been launched in February 2020 by the US FDA on Guidance Snapshots.

These new Guidance Snapshots would be covering topics relating to modernizing drug clinical trials and accelerating drug development.

Three of these snapshots have been released so far. With 2 relating to recommendations on evaluating potential drug-drug interactions (DDIs) for new drugs through clinical and in vitro testing.

The 3rd is focused on developing targeted therapies in low-frequency molecular subsets of a disease.

These snapshots, which are about 2 to 3 pages long, would offer a detailed overview as well as recommendations.

The focus of this pilot program is to increase general public awareness and engagement for FDA guidance documents on innovative topics to support the efficient application of the guidance documents.

It is also warned by FDA that these snapshots should not be misinterpreted as a substitute for the actual guidance.

UK will not be acting as a leading authority for medicines during Brexit transition

March 18, 2020

UK will not be acting as a leading authority for medicines during Brexit transition.

Medicines and Healthcare products Regulatory Agency (MHRA) confirmed in a statement in February 2020 that during the 1-year Brexit transition, the United Kingdom will not be acting as a leading authority for medicines.

The role of a leading authority conducts assessments on behalf of specific EU agencies. Both the UK and EU are still in the midst of a discussion on the activities this article (leading authority) will cover with respect to medicines. However, it is confirmed that medical devices will not be covered.

MHRA’s role in the European Medicines Agency (EMA) and EU committees will see drastic changes with immediate effect from the issuance of the statement. The UK will no longer have voting rights and will have to continue to respect EMA and EU committees’ decisions on drug and device approvals.

The UK is permitted to continue in the participation of decentralized and mutual recognition licensing procedures. But, they are prohibited from acting as a Reference Member State in matters relating to the approval of marketing authorizations. They are also not allowed to act as a rapporteur or co-rapporteur.

Biopharma companies will still be able to continue with batch release testings and Qualified Person certifications in the UK. Marketing authorization holders and qualified persons for pharmacovigilance would still able to be based in the UK and gain access to EU markets.

USA, FDA’s launch of purple book, an online database for biologics

March 16, 2020

The US Food and Drug Administration launched the first version of the Purple Book, which is a searchable online database of biological product information.

The Purple Book will be updated weekly with newly approved biosimilar or interchangeable products, and their respective references being included within 10 working days. All functionality and all BLAs are expected to be available from August 2020.

Once the database is completed, it will allow easier searches to be made and offer information about all licensed biological products, including information ranging from product names, exclusivity, biologics license application submissions.

India’s central government to regulate all medical devices as drugs

March 12, 2020

All medical devices in India will be regulated as drugs under Drugs and Cosmetic Act of 1940 with effect from April 2020.

This regulation would focus on ensuring all medical devices in India meets certain standards of efficacy and quality.

The current statistics showed that only 24 out of over 6,000 medical devices are regulated and being notified as drugs.
This change would potentially lead to a higher input cost, especially for local start-ups.

On the flip side, once devices are regulated they would give investors and surgeons the extra confidence to invest and try the products on patients. It will also inspire start-ups to do further research and innovation on medical devices.

Implementation of eCTD for Clinical Trial Applications in Canada

March 9, 2020

Health Canada would be accepting certain clinical trial submissions in the format of electronic common technical document (eCTD) from 19 February 2020. This comes after a successful pilot that concluded on August 2019.

This will be implemented for pre-clinical trial application consult meetings, clinical trial applications (CTAs), CTA amendments and notifications, as well as all related responses and post-clearance data.

Certain clinical trial regulatory activities and transactions are out-of-scope for filing in eCTD format.

The usage of eCTD format for clinical trial activities is optional for sponsors. Health Canada said in a statement,
“Once a sponsor files a regulatory activity in eCTD format, all additional information and subsequent regulatory transactions for the same dossier (protocol) must also be filed in eCTD format.”, further highlighting that sponsors are not able to revert an eCTD dossier to non-eCTD electronic-only format.

New regulations on Duties and Obligations of Establishments for Medical Devices in Malaysia

March 5, 2020

New regulations on Duties and Obligations of Establishments for Medical Devices in Malaysia

Coming into effect on the 1st of July 2020.

Duties and obligations of this regulation are categorized into 6 categories.

Distribution records

Contents required for a distribution record, implantable medical device distribution record and the period of maintenance required.

Records of complaint handling

Complaint handling procedures and requirements for a record of complaint handling and the holding of a complaint record.

Mandatory problem reporting

This involves submitting the investigation report to the Authority which must be done within 30 days.

Field corrective or preventive action

This states that establishments shall notify the Authority before any field corrective or preventive action is being done.

Voluntary recall

This involves the voluntary recall within the time frames as follows,

Class I (High risk)

No less than 48 hours before the recall is made.

Class II (Medium risk)

No less than 3 days before the recall is made.

Class III (Low risk)

No less than 5 days before the recall is made.

Mandatory recall

The Authority may order a recall of any medical device at any time for reasons of patient safety and public health.

Philippines’ executive order on medicine price cap

February 27, 2020

Philippines’ President Rodrigo Duterte officially signed the executive order which would see a cap set on selected medicines at a maximum retail price.

Under Executive Order No. 104,

“Improving Access to Healthcare through the Regulation of Prices in the Retail of Drugs and Medicines”.

There will be a price regulation set at,

Maximum Retail Price,
Maximum Wholesale Price

On both on certain drugs and medicines.

This comes after an intended proposal of price regulation which involved over 120 drugs for diseases and health conditions.

Under this MDRP scheme, there will be an average price reduction of 56% from market prices.