ADVISORY COUNCIL OF ADMINISTRATIVE REFORM RESULT OF AP’S PRIORITY REVIEW PHARMACEUTICAL SECTOR Presented by Dr. MATTHIAS DUEHN HEAD OF PHARME WORKING GROUP – ADVISORY COUNCIL

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 3

Methodology: 4 Desk review 2nd Group discussion Adding comment & feedback from 1 st meeting Consolidate overall review report EuroCham; AmCham; MOH; OOG; Pharma group Collect legal documents; relevant information 1 st group discussion

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 Vietnam’s 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! 5

AP 2: Registration of foreign new drug 1.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. 6

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). 7 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. 8 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. 9 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. 10 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. 11

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. 12

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. 13 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. 14 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 doesn’t 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. 15 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) 16

11. Receipt of drug registration dossier submission Present situation: NO RECEIPTS. When submitting of drug registration dossier to DAV, DAV’s 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. 17 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 …) 18

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. 19

Recommendation: Revise Article , 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. 20 AP 3: Granting Certificate of "Good Storage Practice" (GSP)

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. 21

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. 22

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. 23

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: 1.Post marketing surveillance/ evaluation only. 2.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. 24

Result of 1 st 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 25

Thank for your attention! 26