Republic of the Philippines Department of Health Food and Drug Administration DRUG - TEAM
2 6 August 2013
Philippine Association of Pharmacists in the Pharmaceutical Industry Philippine Association of Philippine College of Pharmacists in the Pharmaceutical Medicine Veterinary Industry
Total 125 regulations reviewed 54 Administrative Orders 31 Bureau Circulars 21 Memorandum Circulars 2 PSD Memos
Total 125 regulations reviewed 4 FDA Circulars 3 FDA Memorandum Circulars 2 FDA Memorandum 5 Miscellaneous Regulations From 1968 up to 2013
35 Registration REGULATIONS 12 Licensing DEALING 11 with Clinicals 67 Guidelines/Instructions
125 regulations reviewed 54 Updated 28 For deletion 2 Redundant 33 For revision/outdated 7 For further review
in FOCUS
AO 56 s. 1989 Revised Regulations for the RECOMMENDATION Licensing of Drug Establishments and Outlets Definition of Manufacturer To align definition of a manufacturer with the ASEAN definition Specific licensing reqt for Vet manufacturer Chapter 1 2.1.1.3 - Valid Certificate of To consider vet group Registration of the Establishment’s Filipino Pharmacist from PRC 2.1.1.4 – Certificate of State validity of seminar attended attendance to FDA Licensing Clarify accreditation vs. Certificate of seminar Attendance 2.2.1.2 – Books required Add vet books like PNVDF, EP and PVET
AO 56 s. 1989 Revised Regulations for the RECOMMENDATION Licensing of Drug Establishments and Outlets 3.1.1 Period of validity of Review with 2013-2014 Schedule of fees Initial and Renewal; 5.2 Validity and Schedule of Fees 4.3 Reapplication after Revision of the five years requirement is Revocation too long 5.2 Activities engaged by an For review to allow vet to engage in establishment veterinary drugs and products (cosmetics, food, etc)
AO 56 s. 1989 Revised Regulations for the RECOMMENDATION Licensing of Drug Establishments and Outlets Chapter 2 2.2.1.2 – Books required USP – delete Goodman and Gilman - review Prescription books – given more worth Poison books – delet Senior Citizen and Person with Disability Books – to be included Distribution record book for dangerous drugs 2.2.1.5, 2.2.2.4, 4.3.3 To review with pending Pharmacy Law Physical presence of amendment pharmacist when establishment is open 2.2.1.6.2, 4.2.2 – Filing of Review since most Rx are not left with prescriptions, recording pharmacist 2.2.1.6.3, 2.2.2.5.2 Dry seal Delete or rubber stamp
AO 56 s. 1989 Revised Regulations for the RECOMMENDATION Licensing of Drug Establishments and Outlets 2.2.2.1.1 – Signboard To reflect only the name in the signboard 4.1 Temporary closure To review with pending Pharmacy Law amendment REGULATION RECOMMENDATION AO 54 s. 1999 To incorporate ACTD adoption Change of Manufacturers of Drug Products in Compliance with the CGMP Requirements BC 12 s. 2005 To consolidate with MC 15 s. 1992, BFAD Quality Seal Measures of Compliance with Good Manufacturing Practices MC 2 S. 1991 Clarification to secure license to operate for Clarification of "packing" and packing and repacking activities only "repacking" in the definition of drug manufacturer
REGULATION RECOMMENDATION BFAD Reg 1 s. 1988 Should be updated to reflect changing Amended general Regulation regulatory environment (specify) for the Licensing of Drug Establishment MC 2 s. 1990 update sanctions and penalties for non- Compliance with AO 56 s. compliance to the law 1989
AO 67 s. 1989 Revised Rules & Regulations RECOMMENDATION on Registration of Pharmaceutical Products General To accomodate ACTD 2 General Standards Revise annotation re: new registration for new manufacturer; to follow ASEAN Variation 3.3 this should not be based on PNDF if it is a Pharmacological/therapeutic new drug since most probably this is not category yet included in the PNDF. Include provision for drugs not in PNDF 3.5 Branded/Generic Remove patent protection as this is not under FDA's jurisdiction. Update classification, as per current situation: Branded (innovator) Branded (Generics) Generic (generic)
AO 67 s. 1989 Revised Rules & Regulations RECOMMENDATION on Registration of Pharmaceutical Products 3.6 Annotation agreement between FDA and PDEA should be revisited 3.6.4 Drugs requiring strict Update List B drugs precaution in prescribing and dispensing 4.3 Evaluation by testing of Testing of physical attributes against submitted sample Certificate of Analysis 4,5 Action on Registration deficiency letters (NODs, reapplication) Application must be included as an action on registration 4.5.4 MR Validity revise to include current practice for MR products FDA Circular No. 2013-004 (validity of 5 years maximum with no extension for MR registration) 4.7 Grounds for limited revise to include current practice for MR Approval products FDA Circular No. 2013-004 (risk management plan instead of PMS Protocol)
AO 67 s. 1989 Revised Rules & Regulations RECOMMENDATION on Registration of Pharmaceutical Products 5 Renewal to align with current regulation on renewal i.e. Automatic renewal, regular renewal Schedule of Fees update fees ANNEX 1 General align with ACTR Requirements ANNEX 1, General number of labeling materials required must Requirements be aligned with checklist ,5 Number of Label ANNEX 1, Specific revise to include current practice for MR Requirement, 2 New Drug products FDA Circular No. 2013-004 Annex 1, Add'l Reqt delete these parts; not current practice 3 Branded Drug, 5 Investigational Drug, 6 New Drug Annex 1, Add'l Reqt change to include CPP and Export 4 Imported Finished Product Certificate/Free Sale (if product is not marketed in country of origin)
REGULATION RECOMMENDATION BC 05 s. 1997 To accomodate ACTD Revised Checklist of To provide separate checklist for Vet Requirements and the 1997 Products Guidelines for the Registration To adopt ACTD glossary and reclassify of Pharmaceutical Products existing terms vis a vis (i.e. NDA vs NCE) AO 2006-0021 To incorporate FDA Circular 2013-004 – Supplemental Guidelines to PMS AO 67 s.1987: Revised Rules To provide separate checklist for Vet & Regulations on Reg. of Products Pharmac'l Products & BC 5 s.1997 in evaluating NDA AO 2005-0031 To address labeling concerns for LTO Guidelines & Procedures for To provide separate checklist for Vet the Issuance of the PCPR & Products the Listing of Identical Drug Products based on the Identity of Manufacturer & Pharmac'l Formulation
BC 12 s. 1991 To delete in alignment with ACTD Clarification of New Registration when there is a Change of Manufacturer MC 16 s. 1991 To incorporate ASEAN Variation Guideline Conditional Registration for Improvement of Immediate Container of Packaging of Registered Drug Products AO 4 s. 1992 To provide implementation details (i.e., Policy & Requirements for manner of importation) Availing of Compassionate Consider one time issuance for total Special Permit (CSP) for therapy regimen Restricted Use of Unregistered Drug & Device BC 4 s. 1995 Delete following latest issuance of Period within which an Initial schedule of fees Conditional Registration shall be Processed and Issued
AO 169 s. 2004 To incorporate the concept of biosimilars of Implementing guidelines for the WHO/EMEA exclusive use of generic names or generic terminology in all prescriptions and orders in all DOH facilities FDA Memorandum Circular No. Clarification for the types of submission 2013-001-A covered, i.e. Clinical reports, protocol, etc. Amendment- Memorandum Review application of new issuance FDA MC Circular No. 2013-001 Re: 2013-023 Submission of Application for License to Operate (LTO) and Certificate of Product Registration (CPR) With Electronic Copy AO 103 s 2002 To consolidate with other “Batch Certification” Batch Certification of Antibiotics Regulations BC 7 S.2004 BET; Date of stability studies data being Registration of veterinary products submitted; monitored released To provide separate checklist for Vet Products AO 111-A s. 1991 For review pending issuance of JAO/MOA Rules and regulations on between FDA and BAI registration of veterinary drug (Separate Checklist For Veterinary Registration) products
AO 55 s. 1988 Requirements for labeling RECOMMENDATION materials of pharmaceutical products 2.1 Minimum mandatory to allow the option of putting "see information package insert for full prescribing information" or "see package insert for indication, contraindication, precaution and warning" 2.4 Label of the primary there should be a provision for small labels container outside of the PDP i.e. ampules or vials on what minimum mandatory information should be seen 4 Biological Products there should be more detailed labeling requirements for biologicals
AO 55 s. 1988 Requirements for labeling RECOMMENDATION materials of pharmaceutical products 9 Small Containers revisit minimum mandatory requirements stated in 9.2; amount of info vs size of labels and weigh risk-benefit of making the important info readable than overcrowding the small label Consider other means for indicating important drug information on immediate container label 11 Exemption put a clear guideline on criteria for exemption and align with FDA circular 2013-012 RE: Validity of GLE for Pharma Products
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