Objective
- Protect the public and ensure safety of patients and personnel.
- Prevent introduction, transmission, and spread of communicable diseases through quality assurance.
- Ensure stem cell therapies are safe and effective for intended use.
Scope
- Applies to all government and private facilities involved in the use of human stem cell and cell-based or cellular therapies.
Terminology, Abbreviations, and Definitions (Key Terms)
- Definitions cover adverse reactions/events, allogeneic/autologous cells, applicant, bioethics board, Bureau of Health Facilities and Services (BHFS), certificate of accreditation (COA), cellular therapy, clinical program, communicable diseases, standards such as cGTP, cGMP, donors, facilities, genetic manipulation, good manufacturing practices, human tissue and cells, ethical review committees, and others.
- Specific terms include prohibited, restricted, registered/permitted stem cell procedures and products; standard operating procedures; stem cell-based products regulated by Phil. FDA.
Implementing Mechanisms: General Guidelines
- Stem cell therapies to be performed only in DOH-accredited facilities.
- Physicians must inform and educate patients about treatment options.
- Every health facility must have an Institutional Review Committee (IRC) for ethical and scientific review.
- Researchers must obtain protocol approvals from IRC and authorities.
- Non-hospital based facilities must link with a Level 3 DOH-licensed hospital via contract.
- Continuous system establishment for regulatory framework implementation and revision.
- Compliance with standards prescribed by BHFS and Phil. FDA, considering PIC/S guides for GMP and other policy guidelines.
Implementing Mechanisms: Specific Guidelines
Stem Cell Preparations and Therapies:
- Prohibited: Creation of human embryos for research; embryonic stem cells; aborted fetal stem cells; plant parts labeled as stem cells.
- Restricted: Genetically altered human adult or umbilical cord stem cells; adipose-derived stem cells; products subjected to genetic manipulation; live animal (xenobiotic) stem cells for human use.
- Registered and Permitted: Adult human stem cells (autologous and allogeneic) without genetic modification; human umbilical cord stem cells with basic processing; human organ-specific cells.
Bioethics Advisory Board (BAB):
- Chaired by Secretary of Health with members from health, academia, research, and ethics.
- Responsible for ethical standards formulation and addressing legal, scientific issues.
Institutional Review Committee (IRC)/Ethical Review Committee (ERC):
- Responsible for ethical, scientific review of stem cell research and therapy.
- Ensures prohibition of use of banned stem cells, monitors adverse event reporting.
Personnel Requirements:
- Defined organizational structure and staff responsibilities.
- Compliance with cGTP, cGMP, and Phil. FDA regulations.
- Leadership by licensed physician and qualified laboratory head.
- Adequate trained support personnel with consistent training and record maintenance.
Physical Facilities:
- Compliance with government laws and standards.
- Facilities constructed to prevent contamination and spread of infections.
- Designated clinical units, inpatient and outpatient areas with infection control.
Equipment, Reagents, and Supplies:
- Must comply with Phil. FDA standards and include maintenance, calibration, and validation protocols.
- Use of personal protective equipment mandatory.
Work Environment:
- Written safety policies covering infection control, biosafety, emergency response, waste disposal.
- Adequate lighting, ventilation, plumbing.
- Routine cleaning and sanitation with proper documentation.
- Proper waste decontamination and disposal.
- Use of environmental control systems like temperature, humidity, ventilation, HEPA filtration.
Quality Improvement Activities:
- Establish continuous quality improvement system and policies.
- National Kidney and Transplant Institute designated as National Reference Laboratory.
Records Management:
- Maintain patient/donor medical records, research records confidentially for 10 years.
- Detailed logs of complications, adverse events, administrative, technical records.
- Written agreements for third-party services with shared responsibilities.
Procedural Guidelines for Accreditation
- Application: Obtain forms, submit documents including personnel lists, equipment, QAP, certifications, SOPs.
- Review and scheduling of facility survey by BHFS.
- Payment of non-refundable application fees.
- Survey by a team from BHFS, Phil. FDA, NKTI, and BAB.
- BAB decision to approve or disapprove COA issuance.
- Applicants given 15 days to comply if disapproved.
Monitoring
- Annual monitoring of facilities with unannounced inspections allowed.
- Full access to data and information for monitoring.
Validity of Certificate of Accreditation
- COA valid for three years from January 1 to December 31.
Violations
- Violations lead to penalties including suspension or revocation of COA.
- False claims/advertisements regarding cell-based products prohibited.
Investigation of Charges and Complaints
- BHFS and Phil. FDA authorized to investigate and impose sanctions.
- Potential referral to judicial authority for criminal action.
Penalty
- Penalties in accordance with relevant DOH administrative orders and guidelines on licensure, regulation, and good manufacturing practices.
Appeal
- Facility management aggrieved by BHFS/Phil. FDA decision may appeal to Secretary of Health within 10 days.
- Secretary's decision is final and executory.
Repealing Clause
- Previous inconsistent provisions are amended or revoked.
Separability Clause
- Invalid provisions do not affect remaining provisions.
Effectivity
- Order takes effect 15 days after approval and publication.
- Subject to review three years after implementation.