2019 Round-up & What’s upcoming in 2020

As we close the year of 2019. Let’s look at the most interesting stories of the past year and look forward to what’s installed in the start of the new decade.

United States urged the European Union to push back the MDR deadline by 3 years despite the EU commissioner for health making the statement that the deadline will not be adjusted.

European Commission and Medical Device Coordination Group also released several MDR guidance documents on persons responsible for regulatory compliance and implant cards.

FDA issued a total of 10 PRVs in 2019 which included the latest Merck’s Ebola vaccine. So companies can now sell the vouchers and use them to speed the review of new treatments.

UK pushing back BREXIT to the end of January 2020 saw the UK’s Medicines and Healthcare products Regulatory Agency releasing a series of guidance documents to help pharmaceutical and medical device companies.

Looking ahead to 2020,

We would see;

Several important FDA rule makings and guidance documents.

A better understanding on how BREXIT is impacting drug and device supplies in the UK.

FDA to release 2 revised draft guidance on the post market surveillance of devices and post-approval studies.


Malaysia guideline for registration of drug medical device

Fully implemented on 1st July 2019, the guidelines for registration of drug-medical device and medical device-drug combination products in Malaysia.

Medical devices with substances incorporated when used on their own could be considered as a medical product, must adhere to this regulation.

Falling under Class D, Rule 13 of the Medical Device Regulation 2012. A medical device-drug combination product registration require a 3 stage process;

Stage 1 – Obtaining Endorsement from the National Pharmaceutical Regulatory Agency (NPRA)

  • Application form for Endorsement Letter of Ancillary Component for Registration of Combination Product (Appendix 3)
  • Ancillary Drug Dossier (Appendix 2)

Stage 2 – Obtaining Certificate from the Conformity Assessment Body (CAB)

Submit the documentation to the CAB, CAB to issue a certificate and report upon satisfactory assessment.

Stage 3 – Application for Registration to MDA

Obtaining the endorsement letter from the NPRA, certificate and report from the CAB, an application be made on Medcast 2.0 for the MDA to evaluate the medical device application.

International Council For Harmonisation Milestones

International Council for Harmonisation (ICH) updated on the Milestones achieved following their assembly in Singapore. A few guidelines for Step 4 of the ICH process were adopted. They include:

  • Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
  • E9 (R1): Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses
  • M9: Biopharmaceutics Classification

To promote innovation alongside continual improvement in the pharmaceutical sector. At the same time strengthening quality assurance and reliable supply of the product.

Adoption of the Q12 guideline “Particularly Noteworthy” was highlighted.

Concept papers and business plans for the 6 new topics mentioned were also finalized.

  • E6 (R3): Good Clinical Practice.
  • E2D (R1): Post Approval Safety Data Management
  • E20: Adaptive Clinical Trial
  • Q5A (R2): Viral Safety Evaluation of biotechnology Products.
  • S12: Nonclinical Bio distribution. Studies for Gene Therapy Products.
  • M12: Drug Interaction Studies.

2 Concept papers outline discussed previously.

  • M13: Bioequivalence for Immediate-Release Solid Oral Dosage Forms.
  • Q9: Guideline on Quality Risk Management.

Were also approved during this assembly.