USA, FDA launched Guidance Snapshots

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

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.

UK, BREXIT it’s Official. What’s Next ?

UK, As the clock, strikes midnight on 31st January 2020.

The UK would have officially left the European Union and enter a transition period till 31st December 2020.

During this period, the UK will remain in the EU’s customs union and single market and all rights alongside all obligations of companies and citizens will not be affected.

Further negotiations will be taking place for future trade conditions.

These outcomes remain unclear and can range from a Free Trade Agreement/Mutual Recognition Agreement to the UK dealing with the EU on WTO terms.

But, the UK will not be a member of EU institutional organizations.

MHRA and EU institutions will be updating their guidelines reflecting the outcomes via their website:

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

Looking at importing into The Philippines

Importing into the Philippines is pretty a straight forward process.

Provided the guidelines provided by the Bureau of Customs are adhered to.

Goods entering the Philippines’ territories are either regulated, restricted or prohibited due to domestic reasons.

They are classified under the following 4 classes;

  • Free Importation and Exportation
  • Regulated Importation and Exportation
  • Restricted Importation and Exportation
  • Prohibited Importation and Exportation

Hardcopy of Single Administrative Document (SAD) signed  the declarant and customs broker must be submitted to the Formal Entry Division (FED) alongside,

  • Commercial Invoice.
  • Packing List.
  • Duly notarized Supplemental Declaration on Valuation.
  • Duly endorsed Bill of Landing or Airway Bill.
  • All documents that may be required by specific rules and regulations.

Goods declaration must be lodged within 15 days from the date of discharge of the last package from the vessel or aircraft.

Goods imported into the Philippines are subject to duty and taxes upon importation.

Importation would begin when vessel or aircraft enters Philippine’s territories with the intention to unload therein.

 

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 rules being made and new 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.

 

World Health Organisation Latest Guideline on Data Integrity

World Health Organization (WHO) drafted a new guideline on data integrity on 19th November 2019. This highlighted the importance of the reliability of data and information in the production and control of pharmaceuticals.

Due to the recent increase of observations in the integrity of data relating to,

  • Documentation
  • Record Management
  • Good Manufacturing Practice (GMP)
  • Good Clinical Practice (GCP)
  • Good Laboratory Practice (GLP)

The 28-page guideline would assist and recommend companies to use a written data integrity policy. For data documented on paper, WHO warned against the use of pencil, erasers and correction fluid. Companies must ensure that paper records are archived properly by designated personnel in secured and controlled areas.

10 examples of good documentation practices in data integrity are also included in the guideline to offer companies a step by step guide.

Philippines FDA has been officially listed ASEAN MRA for GMP

Philippines FDA has been officially listed under the ASEAN Mutual Recognition Arrangement(MRA) on Good Manufacturing Practices(GMP) for medicinal products. This comes after the 28th ASEAN Consultative Committee On Standards And Quality Pharmaceutical Product Working Group (ACCSQ-PPWG) meeting on 19th & 20th December 2019.

This would result in result in reduced duplication of inspections, cost reduction, facilitation of exports, enhanced market access, enhanced industry reputation, transparency in inspection standards and consistency of inspection, in addition to increasing confidence in the quality of medicines for consumers, reliability and quality of medicines, improved consumer safety and protection, better control of counterfeit medicines, and improved access to affordable quality medicines.

Philippines would be the 5th country to be listed under the ASEAN MRA on GMP for Medicinal Products.

For more details, please refer to Philippines FDA’s press release:

https://www.fda.gov.ph/food-and-drug-administration-included-in-the-asean-mutual-recognition-arrangement-mra/

EMA launch of International Sterile Medicines Inspection Pilot Program

European Medicines Agency (EMA) launched a 2-year pilot that would allow regulators all across the world to share information on good manufacturing practice (GMP) inspections of sterile medicines manufacturing sites.

Specifically, the program will allow information sharing from GMP inspections of manufacturers located in countries that are not participating in the pilot and to promote organize joint inspections.

Lasting a minimum of 2 years, this pilot will involve:

  • EMA
  • US FDA
  • UK’s MHRA
  • France’s ANSM
  • Australia’s TGA
  • Health Canada
  • Japan’s PMDA
  • World Health Organisation

Throughout the program, participants will coordinate and share their inspection plans alongside other participating authorities. This effort will see inspections being done according to predefined GMP requirements, encouraging the coordination of joint inspections rather than sole or concurrent inspections.

This pilot would be applicable to human drugs and certain therapeutic biologics, such as monoclonal antibodies and recombinant proteins, excluding vaccines, cell and gene therapies and plasma-derived products.

ICH guidelines Q12, E9(R1) and M9 adopted following assembly in Singapore

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 to promote innovation alongside continual improvement in the pharmaceutical sector and to strengthen quality assurance and reliable supply of  products. 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

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 were also approved during this assembly:

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

 

 

Vietnam, New Feature on Registration System VNSW

Vietnam Ministry Of Health has introduced a new feature on their registration website system VNSW on 29th October 2019.

This new feature combines 2 registration both import and product license in 1 single website.

As of October 2019, one account in VNSW would suffice for both import license and product registration license.

There will not be any updates required as the registration number on the dossier submitted via the Department Of Medical Equipment and Construction (DMEC) remains unchanged.

This new system would automatically transfer all information to VNSW, allowing quicker follow-ups from the previewer.

 

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