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Minutes for 257Th Meeting Registration Board Held on 24-25Th March, 2016

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Minutes for 257Th Meeting Registration Board Held on 24-25Th March, 2016 Minutes for 257th Meeting Registration Board held on 24-25th March, 2016. Item No. Detail of Item Page No. Item No.I Confirmation of minutes of 256th meeting Registration Board 04 Item No.II Cases referred by Pharmaceutical Evaluation & Registration Division 04 – 285 Item No.III Cases referred by Biological Drugs Division 286 – 363 Item No.IV Cases referred by Quality Assurance & Laboratory Testing Division 364 – 376 Additional cases Item No.V Cases referred by Pharmaceutical Evaluation & Registration Division 377 – 506 Item No.VI Cases referred by Biological Drugs Division 507 - 513 Minutes for 257th Registration Board Meeting 1 257th meeting of Registration Board was held on 24-25th March, 2016 in the Committee Room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting was chaired by Mr. Ghulam Rasool Dutani, Director Pharmaceutical Evaluation & Registration Division, DRAP. The meeting started with recitation of the Holy Verses. The meeting was attended by the following:- 1. Lt General (R) Karamat Ahmed Karamat. Member 2. Maj. Gen. Dr. Aslam Khan, Member Professor of Medicine, Military Hospoital 3. Mr.A.Q.Javed Iqbal Member 4. Sheikh Sarfraz Ahmad Member Additional Draftsman, M/o Law and Justice 5. Mr.Ghulam Mujtaba, Assistant Director Member Representative of IPO 6. Dr.Muhammad Arshad Member President, Pakistan Veterinary Medical Council 7. Dr.Amanullah Khan Member Director Drugs Testing Laboratory Government of Baluchistan, Quetta 8. Dr.Muhammad Khalid Khan Member Director Drugs Testing Laboratory Government of Khyber Pakhtunkhwa, Peshawar 9. Mr.Saleem Butt Member Director Drugs Testing Laboratory Government of Khyber Pakhtunkhwa, Rawalpindi 10. Mr.Abdus Salam Shah Member Director Drugs Testing Laboratory Government of Sindh, Karachi 11. Shaikh Ansar Ahmad, Member Director Biological Drugs, DRAP 12. Mr.Asif Jalil Member Representative of Medical Device Division 13. Dr.Abdur Rasheed Member Chairman, Quality Control Representative of QA&LT Division 14. Dr. Obaidullah, Deputy Director General (Reg.I) Secretary Minutes for 257th Registration Board Meeting 2 Dr.Muhammad Khalid Khan, Ghulam Mujtaba and Dr.Muhammad Arshad attended the meeting on 25.03.2016. Dr.Masud-ur-Rehman (DDG Biological), Zaheer-ud-Din M Babar (DDC R.I/R IV), Muhammad Akhter Abbas (DDC/Incharge, PEC), Dr.Hafsa Karam Elahi (DDC,PEC), Muhammad Amin (DDC R.V / DDC,PEC), Tehreem Sara (DDC RRR), Adnan Faisal Saim (DDC,QC), Babar Khan (ADC R.II/RIII), Dr.Ghazanfar Ali Khan (ADC RRR), Salateen Waseem Phillips (ADC,PEC), Muhammad Ansar (ADC,PEC), Rana Ahsan ul Haq (ADC,PEC) and Muneeb Cheema (ADC,Biological) assisted relevant Directors and Secretary of the Board with agenda. Abuzar Faizi Rattu, Nadeem Alamgeer and Shahzad Hussain attended the meeting as observer on behalf of PPMA, Pharma Beauru and PCDA respectively. In addition to routine agenda, following was also discussed and decided: Registration Board deliberated that drugs for treatment of chronic ailments and drugs which are in short availability should have priority review process and consideration by the Board to ensure their free availability. The Board decided that drugs for treatment of cancer, viral diseases, thalaesemia, immunosuppresants, vaccine and sera, new molecules / formulations, blood factors and bags will be given priority consideration. Registration Board deliberated that as registration letter is being signed by three officers (concerned section / Division officer, Secretary and Chairman, Registration Board), thus on same analogy letter for cancellation / suspension of registration will also be signed by these officers. While discussing agenda of Biological drugs, Chairman, Registration Board re-iteriated that separate Board should be constituted as Biological drugs require thorough examination keeping in view nature of products and their sensitive. Dr.Amanullah Khan, Director Drugs Testing Laboratory, Quetta pointed out that biological products deferred in previous meetings due to certain shortcomings should be placed in agenda of Registration Board meeting after rectification of shortcomings. Minutes for 257th Registration Board Meeting 3 Item No. I: Confirmation of minutes of 256th meeting Registration Board. 256th meeting of Registration Board was held on 03-04th February, 2016. Draft minutes were circulated to all members (who attended the meeting) on 18.02.2016 through e-mail with the request to forward their comments (if any) within 05 days. None of the member forwarded their comments. Decision: Registration Board confirmed minutes of 256th Registration Board meeting. Item No. II: Cases referred by Pharmaceutical Evaluation & Registration Division Case No.01: Grant of registration for export purpose. Registration Board discussed cases for grant of registration for export purpose in various meetings, as per following detail: 240th meeting held on 07th November, 2013 approved standard operating procedure for various processes including grant of registration for export purpose, which is as follows: a. Application on Form 5 with required fee as per relevant SRO. b. NOC for CRF clearance. c. Copy of approved section from CLB. d. Copy of last inspection report. e. An undertaking that applied registration is exclusively for export purpose and will not be sold in Pakistan. f. If formulation / product is not registered in Pakistan, then export order from importing country. 241st meeting held on 23-12-2013 discussed grant of registration of export purpose and decided as follows: a. If formulation is already registered in Pakistan, then Board authorized its Chairman to dispose off the application. b. If formulation is not registered in Pakistan, but has been approved by USFDA, EMA, Australian TGA, regulatory body of Japan or western Europe as drug, then Registration Board will decide the application keeping in view status of the product in aforementioned countries / regulatory authorities. c. If formulation does not fall in above two categories, then applicant will be asked to provide import order from the importing country duly approved by the regulatory Minutes for 257th Registration Board Meeting 4 authority of importing country. Case will be then presented before Registation Board for decision. 246st meeting held on 10-11th December, 2014 discussed grant of registration of export purpose, as follows: Mr.A Q Javed Iqbal, Director QA &LT opined that for export purpose only those formulations should be registered, which are already registered in Pakistan. For new fornulations (which are not registered in Pakistan), manufacturers should first conduct stability studies and then registration for export purpose be granted. Prof. Muzammil H Najmi also endorsed it. Registration Board after deliberation decided that inorder to facilitate export of quality drugs (non-me too drugs), export registration will be granted and manufacturer will comply following conditions before export of drug: Manufacturer will export the product after complying all the conditions as required under Drug Act, 1976 including No objection certificate from concerned DRAP office. Moreover, Federal Inspector of drugs will take sample from each consignemnet for analysis from CDL, Karachi. Manufacturer will also furnish export documents endorsed from custom authorities in order to ensure the export of the product. Registration Board authorized its Chairman for grant of registration for export purpose on contract manufacturing basis excluding controlled drugs and new drug as per contract manufacturing policy. 254th meeting held on 11-12th November, 2015 discussed grant of registration of export purpose and deliberated that formulations which are approved by reference regulatory authorities will be considered for grant of export registrations. Other formulations (not approved by reference regulatory authorities) will be deferred for detailed deliberations in forthcoming meeting. In 256th meeting held on 03-04th February, 2016, PPMA and Pharma Bureau was again advised to submit proposal for grant of registration for export purpose for those formulations which are not approved by reference regulatory authorities. Minutes for 257th Registration Board Meeting 5 Decision: Registration Board deliberated case for grant of export registration in detail. The Board was apprised that registration applications for pharmaceutical export purpose are being processed on priority basis to facilitate registration of drugs by regulatory authority of importing country. Moreover, requirement for registration of drugs is also different in every importing country and it is responsibility / requirement of regulatory authority of country of import to evaluate the registration application and data submitted by the firm for registration of drugs. For disposal of export registration on priority, Registration Board has already taken following decisions: Authorization to Chairman, Registration Board for grant of export registrations of me too / generic drugs including contract manufacturing permissions. Grant of registration by Registration Board for non-me too formulations approved by regulatory authorities of reference countries. Registration Board further decided as follows: Formulations which are not approved by reference regulatory authorities will be considered by the Board if applicant provides evidence of approval status of applied formulation by regulatory authority of importing country. Formulations which have already been registered for export purposes will be granted to other manufacturers for export purpose.
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