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ADVISORY COUNCIL OF ADMINISTRATIVE
REFORM RESULT OF APS PRIORITY REVIEW
PHARMACEUTICAL SECTOR Presented by Dr.
MATTHIAS DUEHN HEAD OF PHARME WORKING GROUP
ADVISORY COUNCIL
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Administrative Procedures Reviewed

1. Granting license to foreign enterprises (to
   conduct drug and pharmaceutical raw material
   business in Vietnam).
2. Registration of foreign drug
3. Granting Certificate of "Good Storage Practice"
   (GSP)
4. Issuing receipt of application dossier for
   medicine advertisement

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Methodology
EuroCham AmCham MOH OOG Pharma group
Collect legal documents relevant information
Adding comment feedback from 1st meeting
Desk review
1st group discussion
2nd Group discussion
Consolidate overall review report
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AP1 Granting license to foreign enterprises to
conduct drug and pharmaceutical raw material
business in Vietnam

• Present requirement
• The duration of license to foreign enterprises
  is currently two (2) years only, whilst MA
  (Marketing Authorization) the duration of license
  for imported drugs for domestic companies in
  Vietnam is five (5) years.
• Obstacles
• This rule is unequal treatment of Vietnamese
  domestic and foreign enterprises and violates
  Vietnams WTO-commitments.
• Recommendation
• Revise Article 11 in TT17/2001/TT-BYT dated
  1/8/2001. We propose to extend the validity
  period for foreign enterprises to five(5) years
  to guarantee equal treatment between foreign and
  domestic enterprises. MOH has already taken up
  this recommendation in Draft 16, so this is
  good news!

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AP 2 Registration of foreign new drug

• Number of dossiers to be submitted
• Present requirement Dossier currently requires
  three (3) document sets (1 original and 2
  hardcopies).
• Obstacles Very burdensome as dossiers are mostly
  100s of pages! Increased admin workload for
  enterprises and difficulty for DAV for filing.
  International best practice 1 original dossier
  and attached CD Rom.
• Recommendation We recommend to only require 1
  original dossier and 1 CD Rom. Revise Article 4
  of drug registration regulation issued with
  QÐ3121/2001/QD-BYT.

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AP 2 Registration of foreign new drug

• 2. Requirement of Certificate of Pharmaceutical
  Product (CPP) from manufacturing country
• Present requirement Obligation to submit CPP
  from country where drug is manufactured.
• Obstacle However, sufficient under EU practice
  CPP of country where drug is registered
  (headquarters), no need to submit CPP of country
  where drug is manufactured.
• Recommendation Replace the CPP of manufacturing
  country by CPP where drug is registered (usually
  company headquarters). Or, replace CPP of
  manufacturing country by Free Sale Certificate
  (FSC) of referential countries under ICH (e.g.
  US, EU and Japan).

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AP 2 Registration of foreign new drug

• 3. Certificate of Analysis (COA) of
  pharmaceutical product with original signature
  from end-manufacturer
• Present requirement Currently, Vietnam requires
  that the CoA must have the original signature
  from end-manufacturer. Vietnam does not accept
  electronic signature (e-signature) on CoA of
  headquarters.
• Obstacles The manufacturing process is often
  done in different countries, and sub-contracted
  to other manufacturers with GMP / GLP (good
  manufacturing/laboratory practice) standards.
  Accordingly, the subcontracted end-manufacturer
  will often not have authority / experience in
  signing CoA, causing time delays of 2 months or
  more.
• Recommendation Accept CoA from a third party
  who gets GMP/GLP certificates (same as local
  drug). Accept e-signature of headquarters on CoA
  which legally has same value.

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AP 2 Registration of foreign new drug

• 4. Identical trade name on Certificate of
  Pharmaceutical Product (CPP)
• Present requirement Currently, the trade name of
  a drug to be used in Vietnam must be exactly the
  same trade name as on the CPP of manufacturing
  country.
• Obstacle However, pharmaceutical companies often
  market/distribute drugs in other
  countries/regions under a different trade name,
  to protect their pricing policies in different
  regions.
• Recommendation We recommend to MOH / Drug
  Administration of Vietnam (DAV) to accept the
  trade name of a drug in Vietnam to be different
  to trade name in CPP of manufacturing /
  registration country.

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AP 2 Registration of foreign new drug

• 5. Certificate of Analysis (COA) for drug
  stability study.
• Present requirement Vietnam currently requires
  different COAs for different stages of stability
  study (to enlarge drug shelf-life).
• Recommendation We recommend removing the
  requirement of different COAs in different stages
  of stability studies, at least for drugs that
  have been approved by US, EU and/or Japan. Where
  such approval has been granted, there is no need
  for additional COAs as drugs have been
  extensively tested under laboratory requirements.

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AP 2 Registration of foreign new drug

• 6. Lead time for dossier evaluation
• Present requirement 12 months (on website it
  says 6 months already). In practice, authorities
  often follow-up via phone after 6 months,
  requiring additional documents. However, no
  receipt, official written statement.
• Recommendation of reducing to 6 months
• In case when after 6 months leadtime for drug
  registration dossier evaluation, there are some
  part or document of the dossier are not evaluated
  ? recommend DAV to give specific timing for
  official feedback of these documents.
• In case the DAV requires complementary document
  or explaination ? recommend DAV acknowledge the
  submission of complementary documents or
  explaination and give a concrect lead time for
  official feedback.

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AP 2 Registration of foreign new drug

• 7. Elimination of one-year validity period for
  some pharmaceutical products
  
• Present requirement Normally, validity of drug
  registration is five (5) years, but in some case
  is 1 year only.
• Obstacles Currently, we do not have clear
  criteria for drug registration with only one year
  validity in regulation. Generally, one year is
  too short time, not enough time for preparation,
  evaluation, approval for registration evaluation
  so it could raise problem in product supply.
• Recommendation Comply with Article 8 of drug
  registration regulation issued with
  QÐ3121/2001/QD-BYT to change 1 year into 5 year
  as other products. In case some drug need special
  control from MOH, enterprise could be required to
  report periodly or application of post evaluation
  mesures.

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AP 2 Registration of foreign new drug

• 8. Requirement of clinical trials in Vietnam for
  innovative medicines
• Obstacles There is not concrete procedure and
  check list for criterias on clinical information
  needed. In case the enterprise does not conduct
  clinical trials in Vietnam, Vietnamese patients
  have to wait 5 year to access innovative drug for
  treatment, even though same drug is approved and
  working in US, EU or Japan!
• Recommendation Establish hard criteria for
  clinical information required for a new drug
  like
• Toxicity on repeated dosages for asian people,
  average weigh 50kg-70kg, in recommended age,
  effective treatment with recommended dosage.
• In case the enterprise decide to choose the
  option of waiting for 5 year after circulating
  in origin country, we recommend the DAV to accept
  the evaluation of drug registration dossier in
  advance and reserve the result in order to grand
  the registration number (visa number)
  immediatelly at the end of 5 year circulating in
  original country.

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AP 2 Registration of foreign new drug

• 9. No automatic data protection
• Present requirement Pharmaceutical company must
  apply for data protection when they apply. This
  is unlike international practice In other
  countries, data of innovative (new) drug (NCE)
  will be automatically protected for 5 years.
• Recommendation Data of innovative drugs should
  be automatically protected for 5 years when
  registration dossier is submitted.

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AP 2 Registration of foreign new drug

• 10. Providing additional information of drug
  safety / Updating leaflets
• Present requirement Approval from MOH for
  updated information on the contraindication on
  drug prescription. Even requirement of written
  authorization of drug authority in origin country
  for any change or complementary contraindication
  (letter Nr 4045/QLD-ÐK dated 23/6/2006, appendix
  3 point 5).
• Obstacles Slow and burdemsome updating process,
  when pharmaceutical enterprise needs to add
  contraindications for one drug, mostly in cases
  when health authority in origin country doesnt
  issue any writing approval but only anounce new
  contraindication on their website (without
  signature and stamp), in theses cases,
  enterprises have to ask for new CPP that could
  take 2- 3 months.

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AP 2 Registration of foreign new drug

• Recommendation  Recommend not to require
  original letter of approval for update or change
  of drug contraindication. Conform with
  international experience Only require submission
  of information from official website of origin
  country (revise Article 17.1 in drug registration
  regulation issued with QÐ3121/2001/QD-BYT)

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AP 2 Registration of foreign new drug

• 11. Receipt of drug registration dossier
  submission
• Present situation NO RECEIPTS. When submitting
  of drug registration dossier to DAV, DAVs staff
  only records information to notebook (number and
  name of company) and inform the receipt number
  verbally.
• Obstacles Enterprises do not have written
  evidence to prove their submission dossier (under
  evaluation) with other authorities and partners
  (i.e. Vietnamese importers, provincial health
  departments , hospitals, custom office...).
• Recommendation DAV should acknowledge in writing
  the dossier submission with at least elementary
  information as date and entry of dossier.

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AP 2 Registration of foreign new drug

• 12. Fees
• Present fee 1,500,000 VND
• Recommendation It needs to differentiate the
  fees for different categories (e.g. new drug
  registration, renewal, generic, complementary
  registration for drug in circulation )

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AP 3 Granting Certificate of "Good Storage
Practice" (GSP)

• Present requirement During 30 days from
  receiving suitable dossier, DAV will give
  decision to set up inspection team to audit GSP
  site.
• Obstacles There is no clear regulation about the
  lead time for audit. No concrete guidline or
  procedure for enterprises in case of not
  conformity (re-submitted dosiier or just complete
  and review internal procedures). No lead time for
  GSP certificate issue from the auditting date.

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AP 3 Granting Certificate of "Good Storage
Practice" (GSP)

• Recommendation Revise Article 2.2.3.2, Part 3 in
  Decision 2701/2001/QÐ-BYT to shorten and clarify
  specific time for evaluation
• Within 15 working days letter to require
  supporting document (if any).
• Within 30 working days Inspectators will audit
  enterprise. The decision should be sent to
  enterprise in advance in order to ease the
  enterprise for preparation.
• Within 5 working days issue certificate for
  coformed site. In case of not comformity, to
  inform enterprise about the reason with
  recommendation of corrective action. After
  receiving report of corrective action from the
  enterprise, the DAV could send audit team to
  re-check the site within 5 open days.

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AP 4 Issuing receipt of application dossier for
drug advertisement

• Present requirement Currently, the MOH applies
  in practice a mechanism of licensing drug
  advertisement (not formal license, but
  advertisement dossier receipt after DAV
  evaluation for suitability.
• Obstacle In practice, the advertisement can only
  be made after 15 days from the receipt date, and
  advertisers will ask for the receipt. Most other
  countries like USA, EU and even China have
  removed this license and replace by strict post
  evaluation.

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AP 4 Issuing receipt of application dossier for
drug advertisement

• Recommendation remove Chapter III in Circular
  13/2009 (dossier, procedure for receiving dossier
  for drug advertisement) and relevant information
  on medicine advertisement in inter Circular No
  01).
• Switch from issuing license (receipt) to post
  evaluation mechanism. The MOH should detail more
  regulations for drug advertisement like allowed
  information (ex. advertise only registered
  information or only within the registered
  indications, administration guidelines). In case
  violation, enterprise should be penalized.
  Therefore, enterprise need to know more about
  legal aspect and control their activities. This
  mechanism is likely applied by most of countries
  in the world.

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Form 3a New drug registration form (Form 4b)

• Present requirement Signature of manufacturer in
  drug registration dossier (each page or overlap
  stamp) required.
• Obstacles Other countries do not have this
  regulation. Register normally keep license for
  selling in Vietnam, register is enterprise who
  operate in Vietnam and is only one who must have
  responsibility for this operation. Take cost and
  time for enterprise.
• Recommendation Revise Article 4, Form 4B-ÐKT,
  Form 6-ÐKT, Form 7-ÐKT in Decision
  3121/2001/QÐ-BYT dated 18/7/2001 on drug
  registration regulation. Take out the requirement
  on signature of manufacturer in drug registration
  dossier and the study of stability. There only
  need signature and stamp of register on
  application form, SPC, sample and design and PI.
  A writing attorney power from manufacturer to
  register could be asked.

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Form 3b Drug quality test before circulation in
market

• Present requirement Require quality test of drug
  by Vietnamese Drug Quality control Institute.
  However, the ability of these institutes does not
  enough to do test, especially for innovative
  drugs (equipments, technology, human
  resource...).
• Recommendation
• Post marketing surveillance/ evaluation only.
• Only require for criteria which are suitable for
  Vietnamese drug quality control centers (no need
  of additional time, equipments or training staff.
  except requirement for reference standards). Lead
  time for test result from receipt of reference
  standards date is required.
• In case of drug quality test is done in Vietnam,
  it needs to
• Clear criteria to indicate kind of drug to be
  tested.
• Ensure feasability of conducting tests in
  Vietnam.
• Give lead time for test result.

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Result of 1st review of Pharma Working Group

• Recommendations for revision of APs 17
  recommendations
• Apply for AP 14 recommendations
• Form of AP 1 recommendation
• Condition of AP 2 recommendations
• Recommendation for cutting of APs 1
  recommendation

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• Thank for your attention!